MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH IMPACTION HANDLE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 6541-4-810

Device Problems Degraded (1153); Material Discolored (1170); Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 05/31/2016

Event Type  malfunction  

Manufacturer Narrative

Reported event: an event regarding santoprene handle degradation was reported.The event was confirmed.Method & results: -device evaluation and results: visual analysis confirmed the reported event.The handle was returned degraded.-medical records received and evaluation: not performed because patient factors did not contribute to the reported event.-device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been 2 similar events for the lot referenced.Conclusions: capa was initiated on 20-oct-2010 because a series of complaints were received for triathlon instrumentation where green santoprene over-mold handles have been reported to be degrading, becoming sticky and unstable.This event was determined to be under the scope of capa.The root cause analysis identified several potential root causes that may have contributed to the reported events.Chemical and cytotoxicity tests showed the degraded santoprene is non-toxic.The ability to clean and sterilize the degraded instruments has not been compromised.Product surveillance will continue to monitor for trends.

Event Description

It has been reported by the kits inspectors that there are some handles that are loosing the rubber and the coloration after cleaning and disinfection.

• Brand Name: IMPACTION HANDLE
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: jadwiga degrado ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5867987
• MDR Text Key: 51819904
• Report Number: 0002249697-2016-02569
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: K143393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 6541-4-810
• Device Lot Number: CR1V02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2016
• Date Manufacturer Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other