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	11/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of a pyrenees tapered driver is worn and not holding the screws outside of the operating room.There is no procedure associated with this reported event, no patient involvement, and no adverse consequence has been reported.
Additional Manufacturer Narrative
A visual inspection was performed.Wear was found on the tip of the device and rotational deformation is observed.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 the tip of the tapered driver is worn and not holding the screws.Direction of the returned device tip deformation indicates it most likely occurred during screw insertion.It was reported that the device was not used at a difficult angle and that excessive force was not applied.Device has been used approximately 50 times and patient had normal bone.The rep reported via phone: "doctor is using these 2-3 days a week with 2-3 cases a day, and we do 2-3 level fusions.High volume for each driver (tapered and non-tapered)".The most likely cause of the reported event was determined to be a high volume of normal use.The degree of wear on the device supports this.It was reported that the surgeon is using these drivers 2-3 days a week with 2-3 cases a day, and that they do 2-3 level fusions.This usage correlates to 1250 - 3750 uses per year.
Event or Problem Description
It was reported that the tip of a pyrenees tapered driver is worn and not holding the screws outside of the or.There is no procedure associated with this reported event, no patient involvement, and no adverse consequence has been reported.

• 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: 13061914
• Report Number: 3004774118-2021-00414
• Device Sequence Number: 13868539
• Product Code: LXH
• UDI-Device Identifier: 10888857030183
• UDI-Public: 10888857030183
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/17/2022

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: 12/06/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 05/18/2022
• 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