• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY ORTHOPAEDICS INC US QUICKSET GRATER HANDLE ASSMB HIP INSTRUMENTS : HANDLES Back to Search Results
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameQUICKSET GRATER HANDLE ASSMB
Type of DeviceHIP INSTRUMENTS : HANDLES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key10959602
MDR Text Key219979360
Report Number1818910-2020-26337
Device Sequence Number1
Product Code HTO
Combination Product (Y/N)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 11/16/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/07/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number244000520
Device LOT NumberSO2009074
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/08/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/15/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-