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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910  ATTUNE BAL SIZER DISTRACTOR; KNEE INSTRUMENT/TRIAL
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DEPUY ORTHOPAEDICS, INC. 1818910  ATTUNE BAL SIZER DISTRACTOR; KNEE INSTRUMENT/TRIAL Back to Search Results
Catalog Number 254400519
Medical Device Problem Code Difficult to Remove (1528)
Health Effect - Clinical Code No Information (3190)
Date of Event 10/17/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event or Problem Description
It was reported that the tensioner is coldwelded together.
 
Additional Manufacturer Narrative
It was reported that the tensioner is cold welded together.The reported event has been evaluated and will be monitored.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 if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
ATTUNE BAL SIZER DISTRACTOR
Common Device Name
KNEE INSTRUMENT/TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910 
700 orthopaedic drive
warsaw IN 46582
MDR Report Key7033924
Report Number1818910-2017-29000
Device Sequence Number944169
Product Code HWT
UDI-Device Identifier10603295384403
UDI-Public10603295384403
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date (Section B) 10/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number254400519
Device Lot NumberABB37682
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2017
Initial Date Received by Manufacturer 10/17/2017
Supplement Date Received by Manufacturer11/21/2017
Initial Report FDA Received Date11/15/2017
Supplement Report FDA Received Date11/27/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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