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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 Problem Loose or Intermittent Connection
Event Date 05/01/2018
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.

 
Event Description

Medical device reprocessing staff identified that item 244000510 was not engaging with the acetabular graters as required for correct functionality. The complained item was subsequently discarded and a replacement is required. No further information is available. Please send replacement item direct to the customer: (b)(6). No charge po to send replacement: will be added to the file when it becomes available shortly. Thank you. Patient consequence? no. Is the information being submitted for this complaint all the details that are known/available regarding this event? yes.

 
Manufacturer Narrative

The instrument associated with this report was not returned. 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 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
chad gibson
700 orthopaedic drive
warsaw , IN 46582-0988
5743725905
MDR Report Key7548797
Report Number1818910-2018-60690
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 05/01/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/29/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number244000510
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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