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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ENGAGE NUT TIGHTENER; HIP INSTRUMENTS : WRENCHES
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DEPUY ORTHOPAEDICS INC US ENGAGE NUT TIGHTENER; HIP INSTRUMENTS : WRENCHES Back to Search Results
Catalog Number 257652100
Medical Device Problem Codes Material Twisted/Bent (2981); Naturally Worn (2988)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/29/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned instrument found the end material to be deformed.The root cause is attributed to heavy usage/wear out.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.
 
Event or Problem Description
It was reported that the engage nut tightener developed burr on end, needs replacing.No surgical delay.
 
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Brand Name
ENGAGE NUT TIGHTENER
Common Device Name
HIP INSTRUMENTS : WRENCHES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key9353489
Report Number1818910-2019-117306
Device Sequence Number16667506
Product Code HXC
UDI-Device Identifier10603295147299
UDI-Public10603295147299
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 08/29/2019
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 Number257652100
Device Lot NumberPG0508
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/04/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/25/2019
Initial Report FDA Received Date11/21/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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