MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK REAMER

Catalog Number UNK REAMER

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Insufficient Information (4580)

Event Date 11/17/2020

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

It was reported that the surgeon reamed the acetabulum to a 54 and attempted to implant a 54 shell.There was no bite on the shell at all so he proceeded to ream up to a 56 and implanted it.This added around 7-10 minutes to the case.He believed the reamer to component relationship was not right.I removed the wasted implant and reamer and had them washed.Surgery prolonged: 7-10 min.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : it is not known if the reamer was from a quickset reamer set or cross-back.It is not possible to determine a product code.A mre cannot be performed.

• Brand Name: UNK REAMER
• Type of Device: REAMER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10958970
• MDR Text Key: 220661421
• Report Number: 1818910-2020-26329
• Device Sequence Number: 1
• Product Code: HTO
• 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
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK REAMER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR