MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. DEPUY ORTHOPAEDICS, INC. PFCSIG OV/DOMPAT 3PEG TRL38MM; KNEE INSTRUMENT/TRIAL

Catalog Number	961102
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/05/2017
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.
Event or Problem Description
Der states that during the revision surgery, the surgeon removed the attune patella and he was attempting to put the new sigma patella trial on the bone.It wouldn't go down, so the surgeon used the patella clamp to put pressure on the patella trial.One of the posts of the 38 mm sigma patella 3 peg trial broke off.The piece of the patella peg trial was retrieved and removed from the wound.
Additional Manufacturer Narrative
The device associated with this report was not returned.Review of the device history records and/or a lot specific complaint database search was not possible as the product lot code required was not provided.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: PFCSIG OV/DOMPAT 3PEG TRL38MM
• Common Device Name: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6914796
• Report Number: 1818910-2017-25906
• Device Sequence Number: 13805026
• Product Code: LXH
• UDI-Device Identifier: 10603295234890
• UDI-Public: 10603295234890
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2017

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: 961102
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 10/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 109