MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM ASSEM UPPER PULL ROD; RECLAIM INSTRUMENTS : INSERTION DEVICES

Catalog Number 297500635

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2017

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 threads on part was stripped while using.It was also reported that it wasn't being threaded in straight.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: the instrument associated with this report was not returned.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 ASSEM UPPER PULL ROD
• Type of Device: RECLAIM INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7150767
• MDR Text Key: 95931330
• Report Number: 1818910-2017-52605
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295156017
• UDI-Public: 10603295156017
• 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: 12/04/2017

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: 297500635
• Device Lot Number: SO2003221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 08/31/2018
• Supplement Dates FDA Received: 09/07/2018
• Date Device Manufactured: 01/25/2012
• 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: 67 YR