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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 Problem Failure to Cut (2587)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/10/2021
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 graters became dull.No surgical delay.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned instrument confirmed the complaint.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.Device history lot : 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 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 Key11856268
MDR Text Key252195270
Report Number1818910-2021-10802
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 05/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2021
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
Device Lot NumberSO2051234
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2021
Date Manufacturer Received06/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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