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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 BIPOLAR HEAD ASSEMBLY TOOL HIP INSTRUMENTS : MISC

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DEPUY INTERNATIONAL LTD - 8010379 BIPOLAR HEAD ASSEMBLY TOOL HIP INSTRUMENTS : MISC Back to Search Results
Catalog Number 855762000
Device Problems Break (1069); Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/13/2019
Event Type  malfunction  
Manufacturer Narrative
(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
It was reported that it was found the screw of the head assembly tool. The head assembly tool had no screw when incoming inspection.
 
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.
 
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Brand NameBIPOLAR HEAD ASSEMBLY TOOL
Type of DeviceHIP INSTRUMENTS : MISC
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK LS11 8DT
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380
6107428552
MDR Report Key8581937
MDR Text Key144262706
Report Number1818910-2019-92526
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 04/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number855762000
Device Lot NumberSM6154809
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/15/2005
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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