MAUDE Adverse Event Report: DEPUY IRELAND 9616671 SIG HP REV TC3 BOX TRIAL SZ3; KNEE INSTRUMENT : FEMORAL TRIALS

Catalog Number	201103013
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2018
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 when the femoral trial assembly were taken apart after the case was done, it was observed that the tc3 revision box trial set screw had broken.All parts were accounted for.No surgical delay noted.
Additional Manufacturer Narrative
Product complaint: (b)(4).Investigation summary: examination of the returned instrument 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.This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.   .

• Brand Name: SIG HP REV TC3 BOX TRIAL SZ3
• Common Device Name: KNEE INSTRUMENT : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 7513737
• Report Number: 1818910-2018-59579
• Device Sequence Number: 1703904
• Product Code: LXH
• UDI-Device Identifier: 10603295081340
• UDI-Public: 10603295081340
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 04/18/2018

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: 201103013
• Device Lot Number: SO2006617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 07/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR