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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 HP IM TIBIA JIG KNEE INSTRUMENT : ALIGNMENT DEVICES

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DEPUY INTERNATIONAL LTD - 8010379 HP IM TIBIA JIG KNEE INSTRUMENT : ALIGNMENT DEVICES Back to Search Results
Model Number 9505-01-203
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/18/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (b)(4). Investigation summary: examination of the returned device confirmed the reported event. 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.
 
Event Description
Blue thumb screw on intramedullary jig is faulty. Used extramedullary alignment guide as the alternative. No surgical delay. Procedure completed without complications.
 
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Brand NameHP IM TIBIA JIG
Type of DeviceKNEE INSTRUMENT : ALIGNMENT DEVICES
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 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr
warsaw, IN 46581-0988
6107428552
MDR Report Key11027428
MDR Text Key222044159
Report Number1818910-2020-27153
Device Sequence Number1
Product Code HTZ
UDI-Device Identifier10603295225119
UDI-Public10603295225119
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 Other Health Care Professional
Type of Report Initial
Report Date 12/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9505-01-203
Device Catalogue Number950501203
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/15/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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