MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MIS 4:1 IMPACTOR/EXTRACTOR; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 6541-7-806

Device Problems Break (1069); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 10/20/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The handle of the impactor broke while impacting during surgery.

Manufacturer Narrative

An event regarding weld fracture of the impactor shaft assembly involving a triathlon mis impactor/extractor was reported.The event was confirmed.Method & results: device evaluation and results: punches/dimpling was observed on the of the impactor shaft and identified as an unapproved manufacturing method of achieving press-fit.The mating features of the impactor shaft and assembly were found to be dimensionally out of specification.Medical records received and evaluation: not performed as there was no indication the event was related to patient factors.Device history review: there were no reported discrepancies.Complaint history review: there have been no other events for the referenced lot.Conclusions: material analysis and dimensional inspection confirmed the impactor shaft press-fit assembly features were not manufactured to specifications.The device is therefore non-conforming.

Event Description

The handle of the impactor broke while impacting during surgery.

• Brand Name: MIS 4:1 IMPACTOR/EXTRACTOR
• 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 navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5226882
• MDR Text Key: 31569155
• Report Number: 0002249697-2015-03761
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2015

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: 6541-7-806
• Device Lot Number: SB3N20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2015
• Initial Date FDA Received: 11/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2008
• 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
• Patient Age: 57 YR