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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910  QUICKSET ACE GRATER HEAD 59MM HIP INSTRUMENTS : REAMERS

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DEPUY ORTHOPAEDICS, INC. 1818910  QUICKSET ACE GRATER HEAD 59MM HIP INSTRUMENTS : REAMERS Back to Search Results
Catalog Number 244000559
Device Problem Separation Problem
Event Date 07/18/2018
Event Type  Malfunction  
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

The top of this grater head as disassociated. Need to be replace. Po to follow. Patient consequence? :no. Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.

 
Manufacturer Narrative

Product complaint # ==> pc-(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

Investigation summary: examination of the returned instrument confirmed the complaint. 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. If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.  .

 
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Brand NameQUICKSET ACE GRATER HEAD 59MM
Type of DeviceHIP INSTRUMENTS : REAMERS
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
chad gibson
700 orthopaedic drive
warsaw , IN 46582-0988
5743725905
MDR Report Key7776454
Report Number1818910-2018-66405
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,O
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/18/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/13/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number244000559
Device LOT NumberA0808
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/27/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/11/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/15/2008
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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