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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 CHARN DBL HND BONE CURET SML HIP INSTRUMENTS : CUTTING INSTRUMENTS

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DEPUY INTERNATIONAL LTD. 8010379 CHARN DBL HND BONE CURET SML HIP INSTRUMENTS : CUTTING INSTRUMENTS Back to Search Results
Catalog Number 962045000
Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Device is an instrument and is not implanted/explanted.
 
Event Description
T-bar has dis-assembled from the instrument (t-bar not broken).
 
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Brand NameCHARN DBL HND BONE CURET SML
Type of DeviceHIP INSTRUMENTS : CUTTING INSTRUMENTS
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD. 8010379
st. anthony's rd
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-XXXX
6107428552
MDR Report Key8353760
MDR Text Key137047261
Report Number1818910-2019-85189
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number962045000
Device Lot NumberYKA-80
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2019
Was Device Evaluated by Manufacturer? Yes
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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