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

Catalog Number 230787003

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

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 tried to pass the 2.5mm guide pin through the metaglene positioner plate and it would not pass.His solution was to run a 2.5mm drill bit through the metaglene positioner plate central hole.There was some silver debris that came off the instrument.Once this was done the guide pin passed through the plate as per design.This probably delayed surgery by 5 minutes.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: the instrument associated with this report was not returned.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: METAGLENE POSITIONER PLATE
• Type of Device: ALIGNMENT DEVICES
• 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 ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7250727
• MDR Text Key: 99315717
• Report Number: 1818910-2018-53009
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10603295116448
• UDI-Public: 10603295116448
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K170748
• 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: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 230787003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2018
• 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