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

Model Number 2975-00-635

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2021

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 pull bar has bent at the top attachment under the threads.It appears not to be straight in line anymore and is bent outwards quite a bit.The 28 head trial is missing a piece of material at the neck junction.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the instrument associated with this report was not returned.Depuy-synthes 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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: RECLAIM ASSEM UPPER PULL ROD
• Type of Device: RECLAIM INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12262231
• MDR Text Key: 264595726
• Report Number: 1818910-2021-16750
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295156017
• UDI-Public: 10603295156017
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/22/2021

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 Model Number: 2975-00-635
• Device Catalogue Number: 297500635
• Device Lot Number: S02030571
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 08/02/2021
• Supplement Dates Manufacturer Received: 09/14/2021
• Supplement Dates FDA Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR