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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 (2407); Insufficient Information (3190)
Patient Problem No Consequences Or Impact To Patient (2199)
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 Name
QUICKSET ACE GRATER HEAD 51MM
Type of Device
HIP 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
MDR Text Key95849217
Report Number1818910-2017-51877
Device Sequence Number1
Product Code HTO
UDI-Device Identifier10603295123989
UDI-Public10603295123989
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
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
1 Patient was 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
Date Manufacturer Received11/27/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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