MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US APG+ SIZER PIN GUIDE 52+0; TRIAL INSTRUMENT

Catalog Number 223600004

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2017

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

It was reported that during a total shoulder performed on (b)(6) 2017, a pin guide broke.All of the pieces were retrieved and a different sized guide was used to complete the procedure.There was no reported surgical delay.

Manufacturer Narrative

Additional narrative: product complaint #
=
> (b)(4).Investigation summary
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> the device associated with this report was not returned.Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot
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> null.Device history batch
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> null.Device history review
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> null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: APG+ SIZER PIN GUIDE 52+0
• Type of Device: TRIAL INSTRUMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7118550
• MDR Text Key: 95066658
• Report Number: 1818910-2017-51717
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295105718
• UDI-Public: 10603295105718
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 223600004
• Device Lot Number: PG233154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2018
• Date Device Manufactured: 10/18/2013
• 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