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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 Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/03/2018
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
Prior to use on patient jnj representative was made aware of the "incorrect sleeves for reamer handles".Tops of reamers disengaging.Surgery was completed.No ae to patient.
 
Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device was returned.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
QUICKSET ACE GRATER HANDLE
Type of Device
HIP 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 Key7903520
MDR Text Key121518383
Report Number1818910-2018-70279
Device Sequence Number1
Product Code HTO
UDI-Device Identifier10603295123798
UDI-Public10603295123798
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number244000510
Device Lot NumberA0308
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/03/2018
Initial Date FDA Received09/24/2018
Supplement Dates Manufacturer Received11/09/2018
Supplement Dates FDA Received11/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/15/2008
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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