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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. UNIVERSAL TAPERED DRIVER; SIZE 10; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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K2M, INC. UNIVERSAL TAPERED DRIVER; SIZE 10; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number 3608-90075
Device Problems Material Deformation (2976); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/19/2022
Event Type  malfunction  
Event Description
A company representative reported that a chesapeake universal tapered driver would not retain the screw.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
 
Event Description
A company representative reported that a chesapeake universal tapered driver would not retain the screw.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
 
Manufacturer Narrative
The device was visually inspected and minor tip deformation was observed with normal wear and tear.The device was functionally tested and it was able to engage with and drive a screw as normal.There is slight resistance when twisting more than 360 degrees but the device is not jamming.A review of complaint history associated with the subject catalog and lot number was performed, and no adverse trends were observed.The tip deformation likely caused the driver to have difficulties engaging the screw in the or causing this failure and while the minor tip deformation could be due to normal wear and tear, an exact cause of the reported event could not be determined.
 
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Brand Name
UNIVERSAL TAPERED DRIVER; SIZE 10
Type of Device
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
K2M, INC.
600 hope parkway se
leesburg VA 20175
Manufacturer (Section G)
K2M, INC.
600 hope parkway se
leesburg VA 20175
Manufacturer Contact
rita karan
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key14418780
MDR Text Key292510521
Report Number3004774118-2022-00191
Device Sequence Number1
Product Code LXH
UDI-Device Identifier10888857082960
UDI-Public10888857082960
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
Type of Report Initial,Followup
Report Date 08/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3608-90075
Device Catalogue Number3608-90075
Device Lot NumberKXXE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/28/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received07/14/2022
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 Reuse
Patient Sequence Number1
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