MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFCSIGMA POST FEM AUG TRL8MMS5; KNEE INSTRUMENT : FEMORAL TRIALS

Catalog Number	961908
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the tip of augment was broken.No surgical delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > examination of the returned device confirmed the reported event.The investigation attributed the root cause to unintended user error.The investigation did not indicate that a broader investigation or corrective action was necessary.Depuy considers the investigation closed at this time.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 POST FEM AUG TRL8MMS5
• Common Device Name: KNEE INSTRUMENT : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9368880
• Report Number: 1818910-2019-117756
• Device Sequence Number: 19429972
• Product Code: JWH
• UDI-Device Identifier: 10603295240464
• UDI-Public: 10603295240464
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 961908
• Device Lot Number: D0896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 12/26/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 12/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR