MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFCSIGMA INS TRL STABL10MMSZ3; KNEE INSTRUMENT/TRIAL

Catalog Number	961441
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
Event or Problem Description
It was reported that the size 3 10mm fb stabilized insert trial cracked in wash.Broken pieces tossed.
Additional Manufacturer Narrative
Examination of the returned device confirmed the reported damage.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFCSIGMA INS TRL STABL10MMSZ3
• Common Device Name: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6710076
• Report Number: 1818910-2017-21045
• Device Sequence Number: 16198389
• Product Code: LXH
• UDI-Device Identifier: 10603295238454
• UDI-Public: 10603295238454
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 961441
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1