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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. QUICKSET ACE GRATER HANDLE HIP INSTRUMENT/TRIAL

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DEPUY ORTHOPAEDICS, INC. QUICKSET ACE GRATER HANDLE HIP INSTRUMENT/TRIAL Back to Search Results
Catalog Number 244000510
Device Problem Device Reprocessing Problem
Event Date 06/17/2016
Event Type  Malfunction  
Manufacturer Narrative

This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. (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

Customer is complaining bodily material coming out of instrument䓠 movable parts after re-processing.

 
Manufacturer Narrative

The device associated with this report was not returned. Review of the device history records and/or a lot specific complaint database search was not possible as the lot code required was not provided. The depuy warsaw sterilization department stated this product was evaluated in an equivalency report that was validated the instrument can be sterilized and cleaned. The investigation could not verify or identify any product contribution to the reported event with the information provided. Based on the investigation, the need for corrective action is not indicated. The investigation could not verify or identify any product contribution to the reported event with the information provided. Based on the investigation, the need for corrective action is not indicated. 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 HANDLE
Type of DeviceHIP INSTRUMENT/TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw , IN 46581
5743725905
MDR Report Key5745621
Report Number1818910-2016-22052
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/17/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/23/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number244000510
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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