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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 49MM; HIP INSTRUMENTS : REAMERS
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DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 49MM; HIP INSTRUMENTS : REAMERS Back to Search Results
Model Number 2440-00-549
Device Problem Failure to Cut (2587)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 11/12/2020
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
Quickset acetabular reamers are dull and cannot remove acetabular bone effectively anymore and need to be replaced.Noticed upon inspection of instrument trays.
 
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
QUICKSET ACE GRATER HEAD 49MM
Type of Device
HIP INSTRUMENTS : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10877554
MDR Text Key217462302
Report Number1818910-2020-25147
Device Sequence Number1
Product Code HTO
UDI-Device Identifier10603295123965
UDI-Public10603295123965
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 11/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2440-00-549
Device Catalogue Number244000549
Was Device Available for Evaluation? No
Date Manufacturer Received01/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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