MAUDE Adverse Event Report: DEPUY IRELAND 9616671 METAGLENE HOLDER INTERNAL ROD; EXTREMITY INSTRUMENTS : HANDLES

Model Number 2307-87-002

Device Problems Material Twisted/Bent (2981); Unintended Movement (3026)

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

Event Date 04/14/2021

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 metaglene inserter does not soundly hold the metaglene.A surgical delay of 5 minutes.

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 INTERNAL ROD
• Type of Device: EXTREMITY INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 11748104
• MDR Text Key: 248159126
• Report Number: 1818910-2021-09203
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295116431
• UDI-Public: 10603295116431
• 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: 04/14/2021

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 Model Number: 2307-87-002
• Device Catalogue Number: 230787002
• Device Lot Number: 5246066
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/14/2021
• Initial Date FDA Received: 04/29/2021
• Supplement Dates Manufacturer Received: 06/09/2021
• Supplement Dates FDA Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1