MAUDE Adverse Event Report: K2M, INC. SCREW DRIVER W/ THREAD; SIZE 10; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	8801-90034
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 2 ozark screwdrivers stripped upon screw insertion intra-operatively.The procedure was successfully completed with no adverse consequences, surgical delay or medical intervention.This report will capture the first of two screwdrivers.
Event or Problem Description
It was reported that 2 ozark screwdrivers stripped upon screw insertion intra-operatively.The procedure was successfully completed with no adverse consequences, surgical delay or medical intervention.This report will capture the first of two screwdrivers.
Additional Manufacturer Narrative
Visual inspection: found the tip of the screwdriver to have rotational deformation.Inner shaft thread is intact.Complaint history records were reviewed for this lot, and no similar complaints were identified.Device ifu and stg were reviewed: for instruments designed for re-use: the life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.Great care must be taken of the instruments to ensure that they remain in good working order.Instruments should be examined for wear or damage by doctors and staff in operating centers prior to surgery.To use the size 10 threaded driver: the size 10 threaded driver has a threaded distal tip to aid in the retention of the screws during insertion.Attach the proximal end of the threaded driver to the torque limiting handle.Insert the distal end of the threaded driver into the screw head and turn the knob clockwise to engage screw.Note: the threaded driver must be used with the 12-in lbs torque limiting handle.Note: the threaded driver will not work with the fast guide.It was reported that patient had hard bone and that excessive force had to be used to insert screw.The most likely cause of the reported event was determined to be due to excessive force applied during screw insertion.

• Brand Name: SCREW DRIVER W/ THREAD; SIZE 10
• Common Device Name: 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 Key: 12740881
• Report Number: 3004774118-2021-00346
• Device Sequence Number: 19192482
• Product Code: LXH
• UDI-Device Identifier: 10888857400863
• UDI-Public: 10888857400863
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8801-90034
• Device Lot Number: PCCY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 01/09/2022
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown