MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV CONV CUT GUIDE SZ 3; RESECTION BLOCKS/DEVICES

Model Number 2504-40-603

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2020

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

Surgeon tried to over-tighten screws attaching the 1-3 broach adapter to size 3 ap cutting block.In doing so, appears to have cross-threaded the left hand screw of the broach adapter and thread on inside of ap cutting block.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: the products were returned to engineering dept at depuy australia where they were assessed by the engineering technician who confirmed the complainants findings.It was deemed that the complaint was due to wear and tear.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE REV CONV CUT GUIDE SZ 3
• Type of Device: RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9656018
• MDR Text Key: 189630262
• Report Number: 1818910-2020-03746
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10603295438427
• UDI-Public: 10603295438427
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2504-40-603
• Device Catalogue Number: 250440603
• Device Lot Number: AB4454390
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1