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U.S. Department of Health and Human Services

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

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DEPUY INTERNATIONAL LTD - 8010379 HP EM TIBIAL JIG ANKLE CLAMP KNEE INSTRUMENT : ALIGNMENT DEVICES Back to Search Results
Model Number 9505-01-229
Device Problems Material Deformation (2976); Mechanical Jam (2983); Naturally Worn (2988)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2021
Event Type  malfunction  
Event Description
Blue locking button was stuck and appears to have been bent and/or crossed threading. Delay to surgery of a few minutes but knob was released and useable though now appears bent. There was no issues with outcome or patient.
 
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 NameHP EM TIBIAL JIG ANKLE CLAMP
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 Key12778975
MDR Text Key280522550
Report Number1818910-2021-24634
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,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9505-01-229
Device Catalogue Number950501229
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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