MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 METAGLENE POSITIONER PLATE; EXTREMITY INSTRUMENTS : ALIGNMENT DEVICES

Model Number 2307-87-003

Device Problems Break (1069); Material Twisted/Bent (2981)

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

Event Date 02/08/2021

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 that the instrument was broken/worn down over time.No surgical delay.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: the device associated with this report was not returned, thus the reported event could not be confirmed.The investigation could not verify or identify any product contribution to the reported event with the information provided.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Corrected: d3.

• Brand Name: METAGLENE POSITIONER PLATE
• Type of Device: EXTREMITY INSTRUMENTS : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 11329721
• MDR Text Key: 232153752
• Report Number: 1818910-2021-03000
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10603295116448
• UDI-Public: 10603295116448
• 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: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2307-87-003
• Device Catalogue Number: 230787003
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR