MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DISTAL RESECTION GUIDE - STANDARD; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 6541-1-721

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/05/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Drill bit got jammed in the distal cutting block.

Manufacturer Narrative

An event regarding alleged seizing of a drill bit in a distal resection guide was reported.The event was not confirmed.Method & results: device evaluation and results: the triathlon distal resection guide was returned in used condition.Overall, the top and bottom of the device were clean and were largely free of cuts, scratches, nicks and burrs.The side of the device showed discoloration and scratching.Note that the drill bit was not returned.Device history review: confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the triathlon distal resection guide was returned in used condition.Overall, the top and bottom of the device were clean and were largely free of cuts, scratches, nicks and burrs.The side of the device showed discoloration and scratching.Note that as the associated drill bit was not returned, evidence of sizing could not be conclusively determined.The event could not be confirmed nor the root cause determined.If additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Drill bit got jammed in the distal cutting block.

• Brand Name: DISTAL RESECTION GUIDE - STANDARD
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5399560
• MDR Text Key: 37151138
• Report Number: 0002249697-2016-00247
• Device Sequence Number: 1
• Product Code: MBH
• 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: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-1-721
• Device Lot Number: SMM7V02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2013
• 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