MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM TAPERED RMR 16X140; RECLAIM INSTRUMENTS : REAMERS

Model Number 2976-16-140

Device Problem Device-Device Incompatibility (2919)

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

Event Date 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

(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 as " refer has the threaded refer removal cold welded together." no surgical delay.

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.

• Brand Name: RECLAIM TAPERED RMR 16X140
• Type of Device: RECLAIM INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11452975
• MDR Text Key: 238950196
• Report Number: 1818910-2021-04804
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295156512
• UDI-Public: 10603295156512
• 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: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2976-16-140
• Device Catalogue Number: 297616140
• Device Lot Number: SO2003218
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1