MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 APG+ SIZER PIN GUIDE 52+0; EXTREMITY INSTRUMENTS : PIN GUIDES

Catalog Number 223600004

Device Problems Crack (1135); Incomplete or Inadequate Connection (4037)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2018

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

After a total shoulder arthroplasty a sterile processing tech noticed a crack in the 52+0 glenoid pin guide.The guide would not firmly attach to the handle and needs to be replaced.This did not effect the surgery or patient.(b)(4).Patient consequence? no.Is the information being submitted for this complaint all the details that are known/available regarding this event? yes.

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: APG+ SIZER PIN GUIDE 52+0
• Type of Device: EXTREMITY INSTRUMENTS : PIN GUIDES
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 6103142063
• MDR Report Key: 7776828
• MDR Text Key: 116896010
• Report Number: 1818910-2018-66447
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295105718
• UDI-Public: 10603295105718
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/16/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 223600004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/16/2018
• Initial Date FDA Received: 08/13/2018
• Supplement Dates Manufacturer Received: 11/27/2018
• Supplement Dates FDA Received: 11/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1