MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS/SIG REV/FEM SLVE TRL 46MM; KNEE INSTRUMENT : FEMORAL TRIALS

Catalog Number	229453140
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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 threads on bolt and sleeve are non functional.
Additional Manufacturer Narrative
(b)(4).Investigation summary:examination of the returned device found the threads have stripped.Depuy synthes considers the investigation closed at this time.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LCS/SIG REV/FEM SLVE TRL 46MM
• Common Device Name: KNEE INSTRUMENT : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8253124
• Report Number: 1818910-2019-81102
• Device Sequence Number: 19371601
• Product Code: LXH
• UDI-Device Identifier: 10603295113768
• UDI-Public: 10603295113768
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2018

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: 229453140
• Device Lot Number: H0206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1