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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*PIN PUNCH; HIP INSTRUMENTS : TAMPS
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DEPUY ORTHOPAEDICS INC US S-ROM*PIN PUNCH; HIP INSTRUMENTS : TAMPS Back to Search Results
Catalog Number 531500
Medical Device Problem Code Material Twisted/Bent (2981)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/20/2018
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 s-rom*pin punch was bent when it was returned from sterile processing.The instrument is in one piece.No surgical delay.
 
Additional Manufacturer Narrative
Pc(b)(4).Examination of the returned instrument confirmed the complaint.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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Common Device Name
HIP INSTRUMENTS : TAMPS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key7684935
Report Number1818910-2018-64353
Device Sequence Number19161488
Product Code LRY
UDI-Device Identifier10603295171591
UDI-Public10603295171591
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 06/20/2018
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 Number531500
Device Lot NumberV1098
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2018
Initial Date Received by Manufacturer 06/20/2018
Supplement Date Received by Manufacturer07/31/2018
Initial Report FDA Received Date07/13/2018
Supplement Report FDA Received Date08/02/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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