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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 SIG HP REV TC3 BOX TRIAL SZ2; KNEE INSTRUMENT : FEMORAL TRIALS
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DEPUY ORTHOPAEDIC INC, 1818910 SIG HP REV TC3 BOX TRIAL SZ2; KNEE INSTRUMENT : FEMORAL TRIALS Back to Search Results
Catalog Number 201103011
Date of Event 09/11/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).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 sig hp rev tc3 box trial sz2 instrument was broken during surgery.
 
Additional 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.
 
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary the instrument associated with this report was not returned.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.Reopen update (b)(4) 2018: device received for evaluation.Examination of the returned device confirmed the reported breakage.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 will be filed as appropriate.
 
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the instrument associated with this report was not returned.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 TC3 BOX TRIAL SZ2
Common Device Name
KNEE INSTRUMENT : FEMORAL TRIALS
Manufacturer (Section D)
DEPUY ORTHOPAEDIC INC, 1818910
700 orthopaedic drive
warsaw 46582
MDR Report Key7915945
Report Number1818910-2018-70751
Device Sequence Number11330181
Product Code LXH
UDI-Device Identifier10603295081326
UDI-Public10603295081326
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date (Section B) 09/11/2018
1 Device 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 Number201103011
Device Lot NumberSO2009306
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2018
Initial Date Received by Manufacturer 09/11/2018
Supplement Date Received by Manufacturer11/16/2018
11/20/2018
11/29/2018
Initial Report FDA Received Date09/27/2018
Supplement Report FDA Received Date11/18/2018
11/22/2018
11/30/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
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