MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 METAGLENE HOLDER; EXTREMITY INSTRUMENTS : HANDLES

Model Number 2307-87-005

Device Problems Structural Problem (2506); Material Twisted/Bent (2981)

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

Event Date 01/07/2021

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

As dr.(b)(6) was trying to implant the delta xtend metaglene component, the blue screw driver in the delta xtend set would not fully lock into the center hole of the metaglene.Dr.D mentioned that the instrument was ineffective.

Event Description

Additional information received states that the instrument seemed worn at the end that engages with the metaglene implant.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.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: METAGLENE HOLDER
• Type of Device: EXTREMITY INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 11193719
• MDR Text Key: 227583009
• Report Number: 1818910-2021-01423
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295116462
• UDI-Public: 10603295116462
• 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: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2307-87-005
• Device Catalogue Number: 230787005
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1