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

Catalog Number	201-90133
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tips of 2 pyrenees non-tapered torque drivers stripped and another one broke intra-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.This report will capture the first of two tip deformations.
Additional Manufacturer Narrative
Visual inspection was performed and confirmed tip rotational deformation.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.Surgical technique guide was reviewed: screw insertion: insert the smartlock bone screws through the plate using the size 10 tapered driver and tighten the bone screw until it begins to engage the plate.The size 10 tapered driver has a tapered, self-holding tip (stab and grab) to aid in insertion of the smartlock screws.Final tightening: after all the smartlock bone screws have been secured, utilize the torque limiting handle in conjunction with the torque limiting hexalobe shaft for final tightening of the bone screws.The torque limiting screwdriver is designed to provide a locking torque of 20 in-lbs (2.3 nm) and help ensure the smartlock technology is fully engaged and not over tightened.The anti-torque instrument is available for both pyrenees constrained and translational.This instrument docks onto the plate and is used as an anti-torque device when final tightening.It was reported that the screws were inserted at a normal angle but slightly more than normal torque was applied.The patient had normal bone.Rotational deformation observed indicates excessive torque was applied to the driver.The most likely cause of the reported event was determined to be due to excessive torque applied during screw insertion.It was reported that event occurred during screw insertion.The tapered driver should be used for screw insertion.Non-tapered torque driver should be used for final tightening with the torque limiting handle.
Event or Problem Description
T was reported that the tips of 2 pyrenees non-tapered torque drivers stripped and another one broke intra-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.This report will capture the first of two tip deformations.

• Brand Name: NON-TAPERED TORQUE 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: 13011577
• Report Number: 3004774118-2021-00392
• Device Sequence Number: 1894186
• Product Code: LXH
• UDI-Device Identifier: 10888857030244
• UDI-Public: 10888857030244
• 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): 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: 201-90133
• Device Lot Number: MNGJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2021
• 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