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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 Problem Dull, Blunt (2407)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/06/2020
Event Type  malfunction  
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 Description
It was reported that the calcar planner was dull and needs to be replaced.
 
Manufacturer Narrative
Product complaint (b)(4).Investigation summary:the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
 
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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 Key10277989
MDR Text Key198944147
Report Number1818910-2020-15928
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 07/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2020
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 NumberABE25282
Was Device Available for Evaluation? No
Date Manufacturer Received08/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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