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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 55MM; HIP INSTRUMENTS : REAMERS
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DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 55MM; HIP INSTRUMENTS : REAMERS Back to Search Results
Model Number 2440-00-555
Device Problem Material Deformation (2976)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 10/05/2020
Event Type  malfunction  
Manufacturer Narrative
(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 55 grater found bent in central sterile.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: 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.
 
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Brand Name
QUICKSET ACE GRATER HEAD 55MM
Type of Device
HIP INSTRUMENTS : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10700191
MDR Text Key211959330
Report Number1818910-2020-22790
Device Sequence Number1
Product Code HTO
UDI-Device Identifier10603295124023
UDI-Public10603295124023
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 10/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2440-00-555
Device Catalogue Number244000555
Was Device Available for Evaluation? No
Date Manufacturer Received12/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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