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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REV TAPERED CEMENT REAMER KNEE INSTRUMENT : REAMERS

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DEPUY ORTHOPAEDICS INC US MBT REV TAPERED CEMENT REAMER KNEE INSTRUMENT : REAMERS Back to Search Results
Model Number 2178-63-106
Device Problems Component Missing ; Material Twisted / Bent
Event Date 02/26/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Investigation summary: examination of the returned device confirmed the missing component. The investigation did not establish that a broader investigation or corrective action was 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 during inspection they noticed that the orange ring inside the canal of the reamer was missing. No further information available.

 
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Brand NameMBT REV TAPERED CEMENT REAMER
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 drive
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw , IN 46581-0988
6107428552
MDR Report Key9889102
Report Number1818910-2020-09463
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Type of Report Initial,Followup
Report Date 02/26/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/27/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number2178-63-106
Device Catalogue Number217863106
Device LOT NumberSO2001743
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/04/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/20/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/28/2012
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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