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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 QUICKSET ACE GRATER HANDLE HIP INSTRUMENT/TRIAL

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DEPUY ORTHOPAEDICS, INC. 1818910 QUICKSET ACE GRATER HANDLE HIP INSTRUMENT/TRIAL Back to Search Results
Catalog Number 244000510
Device Problems Break; Device Reprocessing Problem
Event Date 11/03/2016
Event Type  Malfunction  
Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4). This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.

 
Event Description

Handle was observed to have some kind of residue on it. Handle was sent to spd for cleaning. Residue would not come off and handle cover was dropped and broken.

 
Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.

 
Manufacturer Narrative

Examination of the returned instrument confirmed the complaint. The residue is unknown but is rubbing off by fingernail. Half the sleeve component broke off. The root cause of the fracture is too harsh of chemicals. A two-year search of the complaint database did not identify a trend for either issue for this product code. 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. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw , IN 46581
5743725905
MDR Report Key6090440
Report Number1818910-2016-31187
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/03/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/09/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number244000510
Device LOT NumberSO2007234
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/08/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/21/2012
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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