MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TIBIAL ALIGNMENT HANDLE; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 6541-2-807

Device Problems Degraded (1153); Flaked (1246); Material Integrity Problem (2978)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 11/20/2015

Event Type  malfunction  

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Event Description

It has been reported by the customer that the handle of the product flakes little particles and falls into pieces.

Manufacturer Narrative

An event regarding santoprene handle degradation was reported.The event was confirmed.Method and 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 has been one other event 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.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 has been reported by the customer that the handle of the product flakes little particles and falls into pieces.

• Brand Name: TIBIAL ALIGNMENT HANDLE
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: 5312258
• MDR Text Key: 34355662
• Report Number: 0002249697-2015-04311
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2013
• Device Catalogue Number: 6541-2-807
• Device Lot Number: N1W04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2008
• 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