MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLOBAL UNITE TR BODY SZ14 135; MISC EXTREMITY INSTRUMENT/TRIAL

Catalog Number 210050015

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 06/21/2017

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

Synergy states that the green colour was loose and fell apart but outside the patient and after it has been used.

Manufacturer Narrative

Product complaint # :(b)(4).Investigation summary : examination of the returned device confirmed the reported event.Depuy considers the investigation closed at this time.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: GLOBAL UNITE TR BODY SZ14 135
• Type of Device: MISC EXTREMITY INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7049863
• MDR Text Key: 92952333
• Report Number: 1818910-2017-29574
• Device Sequence Number: 1
• Product Code: LHX
• UDI-Device Identifier: 10603295416098
• UDI-Public: 10603295416098
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 210050015
• Device Lot Number: NW148537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/11/2014
• 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