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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US P.F.C.* FEMORAL HEAD IMPACTOR; HIP INSTRUMENTS : IMPACTORS
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DEPUY ORTHOPAEDICS INC US P.F.C.* FEMORAL HEAD IMPACTOR; HIP INSTRUMENTS : IMPACTORS Back to Search Results
Catalog Number 853962
Medical Device Problem Code Crack (1135)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/27/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(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.
 
Event or Problem Description
It was reported that the head impactor came back cracked from sterile processing department.There was no surgical delay.
 
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Common Device Name
HIP INSTRUMENTS : IMPACTORS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key7709770
Report Number1818910-2018-64936
Device Sequence Number16805161
Product Code KWL
UDI-Device Identifier10603295207795
UDI-Public10603295207795
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K924379
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
Report Date (Section B) 06/27/2018
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 Number853962
Device Lot NumberAY0705
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/27/2018
Initial Report FDA Received Date07/23/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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