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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 59MM; HIP INSTRUMENTS : REAMERS
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DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 59MM; HIP INSTRUMENTS : REAMERS Back to Search Results
Catalog Number 244000559
Device Problem Dull, Blunt (2407)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/31/2020
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 graters have been sharpened several times.Surgeon is complaining that even when they came back from sharpening that they are still dull and not cutting bone like they should.No surgical delay.
 
Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the instrument associated with this report was not returned.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.
 
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Brand Name
QUICKSET ACE GRATER HEAD 59MM
Type of Device
HIP INSTRUMENTS : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10387890
MDR Text Key202357878
Report Number1818910-2020-17818
Device Sequence Number1
Product Code HTO
UDI-Device Identifier10603295124061
UDI-Public10603295124061
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 07/31/2020
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
Device Operator Health Professional
Device Catalogue Number244000559
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/31/2020
Initial Date FDA Received08/10/2020
Supplement Dates Manufacturer Received08/21/2020
Supplement Dates FDA Received08/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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