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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*CONE REAMER,12B-1N HIP INSTRUMENTS : REAMERS

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DEPUY ORTHOPAEDICS INC US S-ROM*CONE REAMER,12B-1N HIP INSTRUMENTS : REAMERS Back to Search Results
Model Number 53-4700
Device Problems Device-Device Incompatibility; Material Twisted / Bent
Event Date 04/09/2020
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

The primary surgery was performed on (b)(6) 2020 via tha. During the surgery, when the surgeon connected the reamer (p/n: 534700) to the shaft (p/n: 534107) and reamed bone-marrow cavity, the shaft came off from the reamer and remained in the bone cavity. The surgeon removed the shaft with a long pean forceps under x-ray. After that, when the surgeon reamed proximal bone because he had difficulty in reducing in the trialing, the shaft came off from the reamer again and remained in the body. The second time, it took time to remove the shaft because the shaft came off at deep point of the bone-marrow cavity despite the nurse tighten the reamer and the shaft. The surgery was completed within 30 minutes delay. It was possible that the patient was inversion position when the surgeon reamed. After the surgery, when the surgeon checked the devices, he could not insert the shaft into the reamer for appropriately depth (some soft tissue or bone chips might adhere the shaft or the reamer because the devices were before cleaning. ). The devices had no problem when the hospital checked before the surgery. No further information is available.

 
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Type of DeviceHIP INSTRUMENTS : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw , IN 46581-0988
6107428552
MDR Report Key9991372
Report Number1818910-2020-11210
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 04/09/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/23/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number53-4700
Device Catalogue Number534700
Device LOT NumberMT1208
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/11/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/15/2008
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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