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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 43MM; HIP INSTRUMENTS : REAMERS
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DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 43MM; HIP INSTRUMENTS : REAMERS Back to Search Results
Catalog Number 244000543
Device Problem Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/04/2020
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 grater had cracks in between grates, it needs to be replaced.They also had impactor tip that was crack.This was discovered by central sterile and did not delay a case.Nobody was injured by crack, they are returning.
 
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.
 
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Brand Name
QUICKSET ACE GRATER HEAD 43MM
Type of Device
HIP INSTRUMENTS : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10403525
MDR Text Key202807198
Report Number1818910-2020-18099
Device Sequence Number1
Product Code HTO
UDI-Device Identifier10603295123903
UDI-Public10603295123903
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 08/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number244000543
Device Lot NumberA0910
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2020
Date Manufacturer Received09/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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