MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 METAGLENE HOLDER INTERNAL ROD

Catalog Number 230787002

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2017

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: (b)(6).Procedure: reverse shoulder replacement.Metaglene holder has bent and won't insert into metaglene or guide.Action taken: used t-handle remover/inserter to insert metaglene.No ae to patient.No delay to procedure.

Manufacturer Narrative

The device associated with this report was not returned for examination.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.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, will be filed as appropriate.

• Brand Name: METAGLENE HOLDER INTERNAL ROD
• Type of Device: INTERNAL ROD
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork 69801 ; EI 69801
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7074777
• MDR Text Key: 93760899
• Report Number: 1818910-2017-50570
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295116431
• UDI-Public: 10603295116431
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 230787002
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1