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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 MBT REVISION REAMER 16MM KNEE INSTRUMENT : REAMERS

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DEPUY ORTHOPAEDIC INC, 1818910 MBT REVISION REAMER 16MM KNEE INSTRUMENT : REAMERS Back to Search Results
Catalog Number 217863176
Device Problem Connection Problem
Event Date 01/10/2018
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 mbt reamers slipping in the modified hudson adapter while reaming bone. No surgical delay.

 
Manufacturer Narrative

Product complaint #: (b)(4). Investigation summary: functional testing of the returned device confirmed the reported event. 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.

 
Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
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Brand NameMBT REVISION REAMER 16MM
Type of DeviceKNEE INSTRUMENT : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDIC INC, 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDIC INC, 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw , IN 46582
5743725905
MDR Report Key7227263
Report Number1818910-2018-52337
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 01/10/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/30/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number217863176
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/31/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/13/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/15/2005
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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