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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 58MM HIP INSTRUMENTS : REAMERS

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DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 58MM HIP INSTRUMENTS : REAMERS Back to Search Results
Catalog Number 244000558
Device Problems Material Discolored (1170); Dull, Blunt (2407)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/17/2018
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 reamers are dull.

 
Manufacturer Narrative

Product complaint # : (b)(4). No device associated with this report was received for examination. 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.

 
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Brand NameQUICKSET ACE GRATER HEAD 58MM
Type of DeviceHIP INSTRUMENTS : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6103142063
MDR Report Key8157026
MDR Text Key130173216
Report Number1818910-2018-77963
Device Sequence Number1
Product Code HTO
Combination Product (Y/N)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,O
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 11/17/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/12/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number244000558
Device LOT NumberA1107
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/12/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/25/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/15/2007
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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