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

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV TIB CEM CONICAL RMR ATTUNE STEMMABLE TIBIA INSTRUMENTS : REAMERS

  • 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 IRELAND - 9616671 ATTUNE REV TIB CEM CONICAL RMR ATTUNE STEMMABLE TIBIA INSTRUMENTS : REAMERS Back to Search Results
Catalog Number 250620103
Device Problem Scratched Material
Event Date 09/05/2019
Event Type  Malfunction  
Manufacturer Narrative

Product complaint # (b)(4). Investigation summary: evaluation of the returned device confirms damage to the reamer. Depuy 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. 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 conical drills were getting hung up in the top of the drill towers and not passing through smoothly. The surgeon questioned wether any of the products were damaged or defective. No surgical delay.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameATTUNE REV TIB CEM CONICAL RMR
Type of DeviceATTUNE STEMMABLE TIBIA INSTRUMENTS : REAMERS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
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 Key9272970
Report Number1818910-2019-113819
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 09/05/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/04/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number250620103
Device LOT NumberNG64604
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/17/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/01/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/29/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-