MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US APG+ SIZER PIN GUIDE 52+0; EXTREMITY INSTRUMENTS : PIN GUIDES

Model Number 2236-00-004

Device Problems Break (1069); Device-Device Incompatibility (2919); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

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

It was reported that the 52+0 sizer pin guide will no longer stay on handle.No surgical delay.

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.H10 additional narrative:  added: b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 (medical device problem code).

Event Description

Additional information received indicated that the part did not break into multiple pieces.The area that attaches to the guide pin handle was deformed and would no longer fit on the handle.

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.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

1.The der is marked yes for pieces being retrieved from patient.Please verify if this was marked by mistake or the instrument broke and was left in the patient? all pieces were retrieved from pieces.2.Is there a deficiency on the handle? if yes.Product details of the handle.Thank you.The handle is still in working order, just the sizing guide was defective.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: APG+ SIZER PIN GUIDE 52+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: 11003478
• MDR Text Key: 221292009
• Report Number: 1818910-2020-26866
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295105718
• UDI-Public: 10603295105718
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/01/2020

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: 2236-00-004
• Device Catalogue Number: 223600004
• Device Lot Number: PG287005
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/14/2020
• Supplement Dates Manufacturer Received: 12/15/2020; 12/22/2020; 01/14/2021
• Supplement Dates FDA Received: 12/18/2020; 12/30/2020; 01/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1