MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN REV FEM 4MM OFFST GDE L; TIBIAL TRIALS

Model Number 2506-30-201

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2020

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 that while inspecting an office set, it was discovered that one of the screws that are used to secure the offset guide to the cutting guide were missing.No surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : examination of the returned device confirms the reported event.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: ATUN REV FEM 4MM OFFST GDE L
• Type of Device: TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10427071
• MDR Text Key: 203638817
• Report Number: 1818910-2020-18409
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295438595
• UDI-Public: 10603295438595
• Combination Product (y/n): N
• PMA/PMN Number: K170748
• 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: 08/07/2020

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: 2506-30-201
• Device Catalogue Number: 250630201
• Device Lot Number: SO2042212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2020
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 08/19/2020
• Supplement Dates Manufacturer Received: 10/02/2020
• Supplement Dates FDA Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1