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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ZT TRIAL SLEEVE 20B SML SLEEVE TRIALS

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DEPUY ORTHOPAEDICS INC US ZT TRIAL SLEEVE 20B SML SLEEVE TRIALS Back to Search Results
Catalog Number 257620100
Device Problems Break (1069); Scratched Material (3020)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/12/2019
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
Metal shavings are coming off trials.
 
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Brand NameZT TRIAL SLEEVE 20B SML
Type of DeviceSLEEVE TRIALS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
st. anthony road
leeds IN 46581
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key9150899
MDR Text Key186138105
Report Number1818910-2019-107482
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 09/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number257620100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/08/2019
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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