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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REVISION REAMER 20MM KNEE INSTRUMENT : REAMERS

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DEPUY ORTHOPAEDICS INC US MBT REVISION REAMER 20MM KNEE INSTRUMENT : REAMERS Back to Search Results
Model Number 2178-63-180
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Code Available (3191)
Event Date 11/04/2020
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 distal femoral jig would not slide over the 20 mm revision reamer. We tried all the other reamers and they worked so it has to be the 20 mm revision reamer. A surgical delay of five minutes.

 
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Brand NameMBT REVISION REAMER 20MM
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
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key10868935
MDR Text Key217140891
Report Number1818910-2020-25004
Device Sequence Number1
Product Code HTO
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 11/04/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/19/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number2178-63-180
Device Catalogue Number217863180
Device LOT NumberNG65392
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/03/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/22/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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