MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET GRATER HANDLE ASSMB; HIP INSTRUMENTS : HANDLES

Catalog Number 244000520

Device Problem Device-Device Incompatibility (2919)

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

Corail reamer handle wouldn't connect to the pinnacle acetabular graters.Reamer handle was unable to be used during surgery, however the 2nd reamer handle worked.Upon inspection of the handle after the surgery, the white outer sleeve was 2 mm noticed to be too long and covered half of the connection nodules, hence why the graters couldn't connect.Surgeon's guess is that the white outer sleeve belongs to the new reamer handles, but was put on an old one.

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.

Manufacturer Narrative

Product complaint #
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>(b)(4) investigation summary
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> the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: examination of the returned instrument cannot confirm the complaint.Depuy-synthes 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.

• Brand Name: QUICKSET GRATER HANDLE ASSMB
• Type of Device: HIP INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10959602
• MDR Text Key: 219979360
• Report Number: 1818910-2020-26337
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/16/2020

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 Catalogue Number: 244000520
• Device Lot Number: SO2009074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 01/26/2021; 03/08/2021; 03/31/2021
• Supplement Dates FDA Received: 01/27/2021; 03/10/2021; 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR