MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 4-8 KEEL PUNCH GUIDE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 6541-2-748

Device Problems Device Reprocessing Problem (1091); Crack (1135); Degraded (1153); Peeled/Delaminated (1454); Material Integrity Problem (2978)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 06/16/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Rubber on handles and impactors are cracked and peeling.Hospital has concerns that containments were being trapped in cracks and not being cleaned well enough.

Manufacturer Narrative

An event regarding santoprene damage involving a size 4-8 keel punch guide was reported.The event was confirmed.A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.The device was returned in used condition.The handles were discolored and degraded.Conclusion: visual inspection showed the device handle was discolored and degraded.The device was discovered during inspection; there was no surgical procedure associated with the reported event.This event meets the definition of preventive maintenance; no further investigation is required at this time.

Event Description

Rubber on handles and impactors are cracked and peeling.Hospital has concerns that containments were being trapped in cracks and not being cleaned well enough.

• Brand Name: SIZE 4-8 KEEL PUNCH GUIDE
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5790220
• MDR Text Key: 50176690
• Report Number: 0002249697-2016-02290
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143393
• 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: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 6541-2-748
• Device Lot Number: N3L14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/16/2016
• Initial Date FDA Received: 07/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2008
• 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