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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HANDLE; HIP INSTRUMENTS : HANDLES
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DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HANDLE; HIP INSTRUMENTS : HANDLES Back to Search Results
Model Number 2440-00-510
Device Problems Material Discolored (1170); Contamination /Decontamination Problem (2895)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/05/2020
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 when sterile processing the manager said it could not verify that the inner surface of the plastic handle is clean or not.It is old and verify discolored and they want it exchanged.No surgical delay.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the instrument associated with this report was not returned.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 HANDLE
Type of Device
HIP INSTRUMENTS : HANDLES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10404417
MDR Text Key202805186
Report Number1818910-2020-18108
Device Sequence Number1
Product Code HTO
UDI-Device Identifier10603295123798
UDI-Public10603295123798
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 08/05/2020
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 Model Number2440-00-510
Device Catalogue Number244000510
Device Lot NumberA0202
Was Device Available for Evaluation? No
Date Manufacturer Received09/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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