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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 INSTRUMENTS : HANDLES

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DEPUY ORTHOPAEDICS, INC. 1818910 QUICKSET ACE GRATER HANDLE HIP INSTRUMENTS : HANDLES Back to Search Results
Catalog Number 244000510
Device Problems Material Discolored; Contamination /Decontamination Problem
Event Date 06/06/2019
Event Type  Malfunction  
Manufacturer Narrative

(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 this style of pinnacle grater handle does not detach at the top to get cleaned properly. Tissue and body fluids gets stuck in them making them contaminated. We are requesting to get them replaced with grater handles that can be taken apart at the top. No surgical delay.

 
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Brand NameQUICKSET ACE GRATER HANDLE
Type of DeviceHIP INSTRUMENTS : HANDLES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester , PA 19380-0988
6103142063
MDR Report Key8735130
Report Number1818910-2019-96868
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 06/06/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/26/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number244000510
Device LOT NumberA0704
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/11/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/15/2004
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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