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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 MBT REV TAPERED CEMENT REAMER KNEE INSTRUMENT : REAMERS

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DEPUY ORTHOPAEDICS, INC. 1818910 MBT REV TAPERED CEMENT REAMER KNEE INSTRUMENT : REAMERS Back to Search Results
Catalog Number 217863106
Device Problems Component Missing; Device-Device Incompatibility; Material Deformation; Scratched Material
Event Date 05/15/2019
Event Type  Malfunction  
Manufacturer Narrative

(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

Stem trials are not able to be securely fixated on end of reamer. Realized during surgery, resulted in no delay. Item did not break into 2 or more pieces. Was surgery delayed due to the reported event? -- no, was procedure successfully completed? -- yes, were fragments generated? -- no.

 
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Brand NameMBT REV TAPERED CEMENT REAMER
Type of DeviceKNEE INSTRUMENT : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester , PA 19380-0988
6103142063
MDR Report Key8666814
Report Number1818910-2019-95182
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 05/16/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/04/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number217863106
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/23/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/15/2005
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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