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

Catalog Number	201-90118
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "wear and tear" was observed on the tips of 2 pyrenees tapered drivers post-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.This report will capture the first of two drivers.
Additional Manufacturer Narrative
Visual inspection was performed which confirms tip wear.There is rotational deformation observed on the tip.Device history records were reviewed for this lot, and no relevant manufacturing issues were identified.Complaint history records were reviewed for this lot, and one similar complaint was identified.Direction of 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.Due to age of the device, tip wear, and deformation observed on the driver, the most likely root cause was determined to be due to excessive force and/or torque applied.Tapered drivers are intended to be used for screw insertion only, not final tightening.Rotational tip deformation on both drivers indicates excessive torque was most likely applied, which can cause device wear.
Event or Problem Description
It was reported that "wear and tear" was observed on the tips of 2 pyrenees tapered drivers post-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.This report will capture the first of two drivers.

• 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: 12961172
• Report Number: 3004774118-2021-00385
• Device Sequence Number: 5409654
• 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): 03/16/2022

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): Initial
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2021
• 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