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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ATTUNE REV TIB CEM CONICAL RMR ATTUNE STEMMABLE TIBIA INSTRUMENTS : REAMERS

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DEPUY ORTHOPAEDICS, INC. 1818910 ATTUNE REV TIB CEM CONICAL RMR ATTUNE STEMMABLE TIBIA INSTRUMENTS : REAMERS Back to Search Results
Catalog Number 250620103
Device Problems Peeled/Delaminated (1454); Mechanical Jam (2983); Scratched Material (3020)
Patient Problem Not Applicable (3189)
Event Date 03/18/2019
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. Device is an instrument and is not implanted/explanted.

 
Event Description

It was reported that the blade of the tibial cemented conical reamer (p/n: 250620103) was caught in the sri attune stemable tibia tower (manufactured by ksi) and it was stuck and the fixed tibia plate was come off during tka surgery on (b)(6) 2019. The surgeon re-placed it and repeated the same process. However, the blade and tower were scraped, and the metal powder was appeared. Thus, the surgeon stopped using the instruments to prevent health damage to the patient. The surgery was completed within a 30 minutes surgical delay. There was no adverse consequence to the patient. It seemed to be an issue of accuracy of the tibia tower and the conical reamer. No further information is available.

 
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Brand NameATTUNE REV TIB CEM CONICAL RMR
Type of DeviceATTUNE STEMMABLE TIBIA INSTRUMENTS : 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 Key8492459
MDR Text Key141233839
Report Number1818910-2019-90124
Device Sequence Number1
Product Code HTO
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberUNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/18/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/08/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number250620103
Device LOT NumberNG64617
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/22/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/23/2017
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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