MAUDE Adverse Event Report: K2M, INC. TAPERED DRIVER; SIZE 10; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	201-90118
Medical Device Problem Codes	Material Deformation (2976); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tips of two pyrenees screwdrivers showed signs of wear and tear, after a procedure.No adverse consequences nor medical intervention were reported.This record captures the first of the two reported pyrenees screwdrivers.
Additional Manufacturer Narrative
Visual inspection confirms rotational tip deformation.There is a step in deformation on the tapered hexalobe approximately one third from the proximal tip.A material analysis was performed on a device from the same lot with the same failure mode to test device hardness, no non-conformities were observed.Device history records were reviewed for this lot, and no relevant issues were identified.Complaint history records were reviewed for this lot, similar complaints were identified.Initial report states that post surgery inspection of the screwdrivers showed wear and tear.It could not be confirmed if the deformation/wear observed occurred during the procedure or prior.The direction of deformation observed indicates that the event occurred during screw insertion.It was reported via follow up phone call that the surgeon uses excessive force to torque the screws down in order to get the plate flush with the bone.Additionally, the surgeon completes a high number of cases, over 140 cases a year, of which most are 2-3 levels.The most likely cause of the reported event was determined to be multi-factorial and the most likely main contributing factor was determined to be excessive torque applied during screw insertion.Lack of use of bone reduction screws may have contributed to event.If bone reduction is required, the bone-reduction screws can be used to achieved additional bone-lagging.Additionally, high volume of normal use may have potentially contributed to the event.
Event or Problem Description
It was reported that the tips of two pyrenees screwdrivers showed signs of wear and tear, after a procedure.No adverse consequences nor medical intervention were reported.This record captures the first of the two reported pyrenees screwdrivers.

• Brand Name: TAPERED DRIVER; 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: 13100904
• Report Number: 3004774118-2021-00416
• Device Sequence Number: 13961267
• Product Code: LXH
• UDI-Device Identifier: 10888857030183
• UDI-Public: 10888857030183
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/18/2022

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: 201-90118
• Device Lot Number: MPYU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2021
• 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