MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 1/8" PEG DRILL; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 6541-4-518

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 09/09/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Triathlon instruments broke during surgery.

Manufacturer Narrative

An event regarding crack/fracture involving a 1/8¿ peg drill was reported.The event was confirmed.Method & results: -device evaluation and results: review with the material analysis engineer indicated "examination of the peg drill indicated it fractured due to a torsional overload condition" part of the peg drill tip has been fractured off.-medical records received and evaluation: not performed as medical records were not provided.-device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been 2 other events for the lot referenced.Conclusions: the investigation concluded that the 1/8¿ peg drill fractured due to a torsional overload condition which was determined by the mar team.

Event Description

Triathlon instruments broke during surgery.

• Brand Name: 1/8" PEG DRILL
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6013540
• MDR Text Key: 57361078
• Report Number: 0002249697-2016-03190
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 12/17/2016

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: Health Professional
• Device Catalogue Number: 6541-4-518
• Device Lot Number: SC3A01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/13/2016
• Initial Date FDA Received: 10/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2008
• 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