MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFCSIG INS TRL STAB12.5MMSZ2.5; KNEE INSTRUMENT : TIBIAL TRIALS

Catalog Number	961432
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
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 torque wrench doesn¿t turn the screwdriver shaft, hudson adapter sticks on the reamers and needs to be removed with mallet and plastic broke on 12.5 x 2.5 ps fixed bearing trial - 2 pieces.All pieces were retrieved.No surgical delay.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Additional narrative: product complaint # = > (b)(4).Investigation summary = > examination of the returned device confirmed the reported event.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot = > null.Device history batch = > null.Device history review = > null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFCSIG INS TRL STAB12.5MMSZ2.5
• Common Device Name: KNEE INSTRUMENT : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7316958
• Report Number: 1818910-2018-54618
• Device Sequence Number: 120135
• Product Code: LXH
• UDI-Device Identifier: 10603295238287
• UDI-Public: 10603295238287
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2018

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: 961432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 03/09/2018; 08/09/2018
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 03/13/2018; 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR