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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIG HP REV 5IN1 CUT BLK SZ5; KNEE INSTRUMENT/TRIAL
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DEPUY ORTHOPAEDICS, INC. 1818910 SIG HP REV 5IN1 CUT BLK SZ5; KNEE INSTRUMENT/TRIAL Back to Search Results
Catalog Number 201103004
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/17/2017
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 when checking in the instrument set it was noted that the adjustable central portion of the size 5 4-in-1 cutting block had seized and needs replacing.
 
Additional Manufacturer Narrative
The device associated with this reported was not returned for evaluation.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
SIG HP REV 5IN1 CUT BLK SZ5
Common Device Name
KNEE INSTRUMENT/TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
MDR Report Key7052601
Report Number1818910-2017-29629
Device Sequence Number2144395
Product Code HTZ
UDI-Device Identifier10603295081258
UDI-Public10603295081258
Combination Product (Y/N)N
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date (Section B) 08/17/2017
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 Number201103004
Device Lot NumberSO2010530
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/17/2017
Supplement Date Received by Manufacturer11/01/2017
Initial Report FDA Received Date11/22/2017
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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