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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 45MM; HIP INSTRUMENTS : REAMERS
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DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 45MM; HIP INSTRUMENTS : REAMERS Back to Search Results
Catalog Number 244000545
Device Problems Corroded (1131); Illegible Information (4050)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/03/2020
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
The itched marking on the acetabular reamers was getting black and spreading around reamer after sterilization.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary - although the device associated with this report was not returned a provided photograph confirmed the complaint.Depuy 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 - null.Device history batch - null.Device history review - null.
 
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Brand Name
QUICKSET ACE GRATER HEAD 45MM
Type of Device
HIP INSTRUMENTS : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key9728636
MDR Text Key190361026
Report Number1818910-2020-05310
Device Sequence Number1
Product Code HTO
UDI-Device Identifier10603295123927
UDI-Public10603295123927
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number244000545
Device Lot NumberSO2022883
Was Device Available for Evaluation? No
Date Manufacturer Received04/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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