| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00956-1 |
| Product Name/Description |
Intramedullary (SP 2 IM) Rod 400mm Instrument
(surgical instrument used in both primary and revision P.F.C. SIGMA knee procedures)
PN 96-6120
Dates manufactured:
4 April 1995 - 22 June 2001 (Material 17-4-SS)
27 August 2008 to 2 October 2012 (Material 455 SS)
Kits containing SP2 IM Rod 400mm Instruments (PN 96-6120) include:
ZZINAUK001
ZZINAUK0605
ZZINAUK9054 (WA ONLY)
ZZINAUK9079 (WA ONLY)
ZZINAUK9094 (WA ONLY)
ARTG Number: 132151 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/09/2015 |
| Responsible Entity |
|
| Reason/Issue |
Complaints have been received that the rod fractured and a portion of the rod was left in the patient. All of the complaints involved the SP2 IM Rod 400mm Instrument made with 455 SS alloy. There is a deep J-shaped groove at the tip of the rod, which allows a sleeve to lock into place when used in revision cases. It is within this groove that fracture can occur. If the affected SP2 IM Rod 400mm Instrument fractures during surgery and a portion of the rod is left in the patient, the possible clinical implications are:
If observed during surgery:
- Significant surgical delay due to attempted retrieval of remaining rod
- Minor bone damage due to attempted retrieval of remaining rod
If not observed during surgery:
- Adverse tissue reaction may occur because the fractured rod, if not removed from within the bone, can act as a stress riser causing remodelling of bone and inflammation
- Pain due to potential bone remodelling or during Magnetic Resonance Imaging (MRI) |
| Recall Action |
Recall |
| Recall Action Instructions |
DePuy will be providing users with swap-out instruments as soon as possible to minimise any surgical disruption. In the meantime, medical professionals may opt to use the other size of the SP2 IM Rod: 300mm SP2 IM ROD (PN 96-6121). If a surgeon performed a procedure with an affected instrument and experienced a fractured instrument, the company recommends that surgeon users discuss potential clinical implications and risks with symptomatic patients. This action has been closed-out on 06/09/2016. |
| Contact Information |
1300 562 711 - Customer Service |