MAUDE Adverse Event Report: DEPUY IRELAND 9616671 SIG HP REV TC3 BOX TRIAL SZ4; KNEE INSTRUMENT : FEMORAL TRIALS

Catalog Number 201103014

Device Problems Bent (1059); Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the sigma box trial size 4 and size 5 mechanism that tightens the box to the femur trial was bent and cracked.The box trial would not fully seat onto the femur trial.No pieces were broke off just need to be replaced.No surgical delay.

Manufacturer Narrative

Product complaint # pc-(b)(4).Investigation summary the device associated with the reported event was not returned for evaluation.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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: SIG HP REV TC3 BOX TRIAL SZ4
• Type of Device: KNEE INSTRUMENT : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7502071
• MDR Text Key: 107835426
• Report Number: 1818910-2018-59263
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295081357
• UDI-Public: 10603295081357
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 201103014
• Device Lot Number: SO2002016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2018
• Initial Date FDA Received: 05/10/2018
• Supplement Dates Manufacturer Received: 10/23/2018
• Supplement Dates FDA Received: 10/23/2018
• Date Device Manufactured: 06/22/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 56 YR