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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 PROXIMA MI CALCAR REAMER SMALL; HIP INSTRUMENTS : REAMERS
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DEPUY INTERNATIONAL LTD - 8010379 PROXIMA MI CALCAR REAMER SMALL; HIP INSTRUMENTS : REAMERS Back to Search Results
Model Number 9400-80-007
Device Problems Dull, Blunt (2407); Naturally Worn (2988)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2020
Event Type  malfunction  
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.
 
Event Description
It was reported that the calcar planers have been worn down and dulled due to prolonged use and no longer plane the bone down on the calcar.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary examination of the returned instrument confirmed the complaint.Depuy-synthes 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.H10 additional narrative:.
 
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Brand Name
PROXIMA MI CALCAR REAMER SMALL
Type of Device
HIP INSTRUMENTS : REAMERS
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK  LS11 8DT
MDR Report Key10309190
MDR Text Key199903815
Report Number1818910-2020-16547
Device Sequence Number1
Product Code HTO
UDI-Device Identifier10603295223627
UDI-Public10603295223627
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9400-80-007
Device Catalogue Number940080007
Device Lot NumberABC14825
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2020
Date Manufacturer Received08/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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