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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 MBT REVISION REAMER 18MM KNEE INSTRUMENTS

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DEPUY ORTHOPAEDICS, INC. 1818910 MBT REVISION REAMER 18MM KNEE INSTRUMENTS Back to Search Results
Catalog Number 217863178
Device Problem Fitting Problem
Event Date 10/03/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.

 
Event Description

The attachment for this 18mm mbt reamer is stripped. The t-handle and reamer attachment do not lock onto the reamer.

 
Manufacturer Narrative

The device associated with this complaint was not returned for examination. A complaint database search against the reported product code found previous reports for this failure that when confirmed were attributed to product wear out. The investigation could not identify or verify any product contribution to the current reported event without the device to examine. Based on the inability to determine a root cause, a need for corrective action is not indicated. Monitor complaints through sep-(b)(4). 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.

 
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Brand NameMBT REVISION REAMER 18MM
Type of DeviceKNEE INSTRUMENTS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw , IN 46581
5743725905
MDR Report Key6013558
Report Number1818910-2016-28789
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/03/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/10/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number217863178
Device LOT NumberNG0310
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/15/2010
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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