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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 Loose or Intermittent Connection; Device-Device Incompatibility; Naturally Worn
Event Date 04/09/2018
Event Type  Malfunction  
Manufacturer Narrative

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 stem tightening device is stuck and will not turn. Reamer adapter will not hold the reamers. Reamer adapter t handle will not hold the reamers. All of the reamers written up will not stay connected in the adapter; they slip.

 
Manufacturer Narrative

Product complaint #: (b)(4). Investigation summary: the device associated with this report was not returned for evaluation. The investigation could not draw any conclusions about the reported event without the device to examine. Depuy considers the investigation closed. 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, a follow-up medwatch will be filed as appropriate.  .

 
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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
6107428552
MDR Report Key7479347
Report Number1818910-2018-58731
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 04/09/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/02/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number217863106
Device LOT NumberSO2026957
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/15/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/29/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/04/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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