MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 TC3 RP TIB INS TRL SZ 2.5 12.5; KNEE INSTRUMENT : TIBIAL TRIALS

Catalog Number	963332
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2018
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
It was reported that 2 115 x 12 stem trials broke while impacting, all parts retrieved.It was also indicated that the 2.5 x 12 mm insert trial metal post bent.No surgical delay.Parts will be returned.Examination of the four returned tc3 rp tib ins trl confirmed the pin components have partially migrated out of the trial bodies resulting in a tilted position.There is random significant scarring and gouging.The overall condition of the devices indicate moderate usage. .

• Brand Name: TC3 RP TIB INS TRL SZ 2.5 12.5
• Common Device Name: KNEE INSTRUMENT : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7663648
• Report Number: 1818910-2018-63796
• Device Sequence Number: 1979567
• Product Code: LXH
• UDI-Device Identifier: 10603295246220
• UDI-Public: 10603295246220
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 06/21/2018

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: 963332
• Device Lot Number: CY0705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 07/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1