MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE DISTAL FEMORAL JIG; ATTUNE INSTRUMENTS : ALIGNMENT DEVICES

Catalog Number 254400521

Device Problems Material Twisted/Bent (2981); Naturally Worn (2988)

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

Event Date 06/29/2021

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 numbers on the jig are worn and cannot be read.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary - no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot - no lot information available.Corrected: h6 medical device problem code.

• Brand Name: ATTUNE DISTAL FEMORAL JIG
• Type of Device: ATTUNE INSTRUMENTS : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12175396
• MDR Text Key: 261771354
• Report Number: 1818910-2021-15322
• Device Sequence Number: 1
• Product Code: HWT
• 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: 06/29/2021

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 Catalogue Number: 254400521
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/15/2021
• Supplement Dates Manufacturer Received: 08/16/2021
• Supplement Dates FDA Received: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1