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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 QUICKSET ACE GRATER HEAD 51MM HIP INSTRUMENT

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DEPUY ORTHOPAEDICS, INC. 1818910 QUICKSET ACE GRATER HEAD 51MM HIP INSTRUMENT Back to Search Results
Catalog Number 244000551
Device Problems Dull, Blunt; Insufficient Information
Event Date 01/01/2017
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

In surgery, surgeon complained the reamers was not enough sharp to work po # (b)(4). Patient consequence? :no. Action taken for procedure:completed with other reamers.

 
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Brand NameQUICKSET ACE GRATER HEAD 51MM
Type of DeviceHIP INSTRUMENT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic dr.
warsaw , IN 46582
5743725905
MDR Report Key7125157
Report Number1818910-2017-51877
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/27/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/18/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number244000551
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 Received11/27/2017
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 Unkown

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