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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 53MM; HIP INSTRUMENTS : REAMERS
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DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 53MM; HIP INSTRUMENTS : REAMERS Back to Search Results
Model Number 2440-00-553
Device Problems Material Deformation (2976); Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/22/2021
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 that the grater is bent and wobbles.No additional information.No surgical delay.
 
Manufacturer Narrative
Product complaint # : pc-(b)(4).Investigation summary : no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
 
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Brand Name
QUICKSET ACE GRATER HEAD 53MM
Type of Device
HIP INSTRUMENTS : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12160830
MDR Text Key261311744
Report Number1818910-2021-15062
Device Sequence Number1
Product Code HTO
UDI-Device Identifier10603295124009
UDI-Public10603295124009
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 06/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2440-00-553
Device Catalogue Number244000553
Was Device Available for Evaluation? No
Date Manufacturer Received07/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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