• 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 MBT REVISION REAMER 18MM KNEE INSTRUMENT : 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 ORTHOPAEDICS INC US MBT REVISION REAMER 18MM KNEE INSTRUMENT : REAMERS Back to Search Results
Catalog Number 217863178
Device Problems Fitting Problem; Device-Device Incompatibility
Event Date 10/04/2019
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. Occupation is a non-healthcare professional.

 
Event Description

It was reported that the reamer will not stay in reamer adapter. It falls off when reaming deep into the canal. No surgical delay.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMBT REVISION REAMER 18MM
Type of DeviceKNEE INSTRUMENT : REAMERS
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
1210 ward avenue
west chester , PA 19380
6107428552
MDR Report Key9249786
Report Number1818910-2019-112799
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/04/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/29/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number217863178
Device LOT NumberNG32447
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/14/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/27/2012
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-