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

Catalog Number 201103014

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2018

Event Type  malfunction  

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 Description

It was reported that the feet are bent on box trial so not fitting into trial.No surgical delay.

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

Manufacturer Narrative

Product complaint #: (b)(4).

• Brand Name: SIG HP REV TC3 BOX TRIAL SZ4
• Type of Device: FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7258859
• MDR Text Key: 99805648
• Report Number: 1818910-2018-53100
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295081357
• UDI-Public: 10603295081357
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• 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,Followup,Followup
• Report Date: 01/24/2018

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: SO2002034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2018
• Initial Date FDA Received: 02/09/2018
• Supplement Dates Manufacturer Received: 02/09/2018; 02/09/2018; 04/26/2018
• Supplement Dates FDA Received: 02/15/2018; 02/15/2018; 05/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2012
• 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: 61 YR