MAUDE Adverse Event Report: DEPUY IRELAND 9616671 RECLAIM BOLT TORQ WRENCH HNDL; RECLAIM INSTRUMENTS : WRENCHES

Catalog Number 297500300

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2018

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

(b)(4).The torque function in the t-handle seems to have gone and when connected to the pronged stem stabiliser- they wouldn't disconnect - there seems to be some visual damage at the connection.

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.

Manufacturer Narrative

Product complaint # pc-(b)(4).Investigation summary examination of the returned instrument confirmed the complaint.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 will be filed as appropriate.

• Brand Name: RECLAIM BOLT TORQ WRENCH HNDL
• Type of Device: RECLAIM INSTRUMENTS : WRENCHES
• 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: 7600611
• MDR Text Key: 111018582
• Report Number: 1818910-2018-62165
• Device Sequence Number: 1
• Product Code: HXC
• UDI-Device Identifier: 10603295155898
• UDI-Public: 10603295155898
• Combination Product (y/n): N
• 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,Followup
• Report Date: 05/22/2018

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: 297500300
• Device Lot Number: SO2005250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 06/14/2018
• Supplement Dates Manufacturer Received: 07/26/2018; 09/10/2018
• Supplement Dates FDA Received: 08/01/2018; 09/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1