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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 Break; Material Discolored; Scratched Material
Event Date 01/03/2019
Event Type  Malfunction  
Manufacturer Narrative

Product complaint # (b)(4). Investigation summary: examination of the returned instrument found the instrument to be damaged. 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. (b)(4) reported broken acetabular reamer handle. Examination of the returned instrument did not find any breakage on the handle. Visual examination did find the sleeve to be discolored and scratched from heavy usage. There was also some scratches on the hudson attachment end that could make it difficult to engage with a mating part or connect to power. The complaint sample consisted of (1) 244000510 quickset ace grater handle, date code a0607. The date code indicates the instrument was manufactured in june of 2007 and is over 11 years old. Based on the age and condition of the instrument, the root cause will be attributed to a combination of misuse and heavy usage. 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.

 
Event Description

Broken acetabular reamer handles.

 
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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
6103142063
MDR Report Key8398701
Report Number1818910-2019-86666
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/22/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/07/2019
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number244000510
Device LOT NumberA0607
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/22/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/06/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/15/2007
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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