MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PATELLA CLAMP; INSTRUMENT

Catalog Number 6541-3-600

Device Problems Sticking (1597); Unstable (1667)

Patient Problem No Information (3190)

Event Date 04/07/2014

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that while checking instruments, i noticed the rubber handles on the patella clamp, and the patella caliper were sticky and the rubber appears to be unstable and easily scraped with a finger nail.

Manufacturer Narrative

An event regarding degraded handles involving a triathlon patellar clamp was reported.The event was confirmed.Method and results: device evaluation and results: visual analysis confirmed the reported event.Medical records received and evaluation: not performed because it is believed patient factors did not contribute to the reported event.Device history review indicated all devices accepted into stock met specification.Complaint history review indicated there have been no other events associate with the reported lot.Conclusion: capa was initiated 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.Chemical and cytotoxicity tests showed the degraded santoprene is non-toxic.The ability to clean and sterilize the degraded instruments has not been compromised.

Event Description

It was reported that while checking instruments i noticed the rubber handles on the patella clamp, and the patella caliper were sticky and the rubber appears to be unstable and easily scraped with a finger nail.

• Brand Name: PATELLA CLAMP
• Type of Device: INSTRUMENT
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3781414
• MDR Text Key: 19396787
• Report Number: 0002249697-2014-01575
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 6541-3-600
• Device Lot Number: C3S18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2009
• 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