MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US APG+ SIZER PIN GUIDE 48+0; EXTREMITY INSTRUMENTS : PIN GUIDES

Model Number 2236-00-003

Device Problems Break (1069); Device-Device Incompatibility (2919); Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 09/08/2020

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

During global unite anatomic shoulder replacement, whilst sizing the glenoid with a clear plastic sizing / pin placement guide, size 48 mm, the surgeon was unable to remove the guide (which was attached to the guide handle).The guide became detached from the handle.He then used a kocker / forceps instrument to remove the guide, with some force, as the guide was caught on a retractor.The guide then broke, cleanly, in half - all pieces were removed from the wound - inspected by the surgeon.Surgical delay of 5 minutes.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary examination of the returned device confirmed the reported event.The investigation did not establish that a broader investigation or corrective action was necessary.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Patient code: no code available ((b)(4)) is used to capture insufficient information.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: APG+ SIZER PIN GUIDE 48+0
• Type of Device: EXTREMITY INSTRUMENTS : PIN GUIDES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10568281
• MDR Text Key: 207975854
• Report Number: 1818910-2020-20688
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295105701
• UDI-Public: 10603295105701
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 2236-00-003
• Device Catalogue Number: 223600003
• Device Lot Number: PG232795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 09/22/2020
• Supplement Dates Manufacturer Received: 10/13/2020; 10/28/2020
• Supplement Dates FDA Received: 10/20/2020; 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR