MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 MODULAR CALCAR PLANER LRG; REAMERS

Model Number 2570-04-503

Device Problem Unintended Movement (3026)

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

Event Date 02/19/2021

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 surgeon complained that he thought the calcar reamer was bent and causing is to wiggle side to side while spinning on power.Doesn¿t appear to be bent but wanted replaced in case.No surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : examination of the returned instrument found the alleged complaint unconfirmed but found a different failure upon inspection of the instrument.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: MODULAR CALCAR PLANER LRG
• Type of Device: REAMERS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12206172
• MDR Text Key: 262943510
• Report Number: 1818910-2021-15677
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 10603295482031
• UDI-Public: 10603295482031
• 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: 06/01/2021

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: 2570-04-503
• Device Catalogue Number: 257004503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 07/21/2021
• Supplement Dates Manufacturer Received: 07/22/2021
• Supplement Dates FDA Received: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR