MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 ROD FOR REAMING GUIDE HOLDER; REVERSE SHOULDER INSTRUMENT

Catalog Number 230774002

Device Problem Bent (1059)

Patient Problem Not Applicable (3189)

Event Date 05/23/2018

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Reverse shoulder replacement.Revision date: (b)(6) 2018.Tip of instrument bent during humeral preparation.Tried to straighten tip.Requires replacing.Five (5) minutes delay in surgery.Pictures available.

Manufacturer Narrative

Product complaint # : (b)(4).The device associated with this reported event was not returned for evaluation.Review of an provided photograph confirmed the reported bent condition.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will 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: ROD FOR REAMING GUIDE HOLDER
• Type of Device: REVERSE SHOULDER INSTRUMENT
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 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: 7610779
• MDR Text Key: 111447628
• Report Number: 1818910-2018-62462
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295116134
• UDI-Public: 10603295116134
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 230774002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1