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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HANDLE HIP INSTRUMENTS : HANDLES

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DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HANDLE HIP INSTRUMENTS : HANDLES Back to Search Results
Model Number 2440-00-510
Device Problems Mechanical Jam; Physical Resistance / Sticking
Event Date 10/31/2019
Event Type  Malfunction  
Manufacturer Narrative

Product complaint #: (b)(4). Investigation summary: examination of the returned instrument could not confirm the reported observation. 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. Territory (b)(4) reported that all grater handles are beginning to lose functionality, whether pieces are becoming stuck or faulty. A functional check with a mating grater head found the reported complaint unconfirmed; grater handle was able to be pulled down and assemble/hold grater head. The complaint sample consisted of (1) 244000510 quickset ace grater handle. Based on the investigation, the need for corrective action is not indicated. Complaints will be monitored under post market surveillance (b)(4) if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
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

It was reported that all grater handles are beginning to lose functionality, whether pieces are becoming stuck or faulty. All 10 will be sent back to be examined.

 
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Brand NameQUICKSET ACE GRATER HANDLE
Type of DeviceHIP INSTRUMENTS : HANDLES
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
1210 ward avenue
west chester , PA 19380-0988
6103142063
MDR Report Key9367711
Report Number1818910-2019-117723
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 10/31/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/25/2019
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number2440-00-510
Device Catalogue Number244000510
Device LOT NumberA0906
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/15/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/15/2006
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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