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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET GRATER HANDLE ASSMB; HIP INSTRUMENTS : HANDLES
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DEPUY ORTHOPAEDICS INC US QUICKSET GRATER HANDLE ASSMB; HIP INSTRUMENTS : HANDLES Back to Search Results
Catalog Number 244000520
Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/15/2021
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 as "these reamers need to be replaced, they are the ones that fall apart real easy.Need them replaced with a different version.".
 
Manufacturer Narrative
Product complaint #
=
> (b)(4) investigation summary
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> 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.Device history review
=
> the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
 
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Brand Name
QUICKSET GRATER HANDLE ASSMB
Type of Device
HIP INSTRUMENTS : HANDLES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12107418
MDR Text Key259636104
Report Number1818910-2021-14223
Device Sequence Number1
Product Code HTO
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,Followup
Report Date 06/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number244000520
Device Lot NumberA0111
Date Manufacturer Received08/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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