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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 Problems Corroded (1131); Material Discolored (1170)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/20/2018
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

Corrosion and color changes are observed on the products.

 
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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 Key7334342
MDR Text Key102227484
Report Number1818910-2018-54980
Device Sequence Number1
Product Code HTO
Combination Product (Y/N)N
Reporter Country CodeTU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/20/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/13/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number244000559
Device LOT NumberA0111
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/15/2011
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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