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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 HP EM TIBIAL JIG SPIKED UPROD KNEE INSTRUMENT : ALIGNMENT DEVICES

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DEPUY INTERNATIONAL LTD - 8010379 HP EM TIBIAL JIG SPIKED UPROD KNEE INSTRUMENT : ALIGNMENT DEVICES Back to Search Results
Model Number 9505-01-230
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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
The above hospital have the following device which has bent in use. Tibial jig spiked up rod ref 950501230 lot number a0308 reported today. Surgery not delayed no adverse effects for patient.
 
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Brand NameHP EM TIBIAL JIG SPIKED UPROD
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
1210 ward av
west chester, PA 19380
6107428552
MDR Report Key13112054
MDR Text Key284904952
Report Number1818910-2021-28964
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9505-01-230
Device Catalogue Number950501230
Device Lot NumberA0308
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/17/2022
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 Unkown

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