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

Catalog Number	201-90133
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the pyrenees non-tapered torque driver broke off into the screw head intra-operatively, during final tightening.The fractured component was left in the screw.The procedure was completed successfully without surgical delay.No adverse consequences nor medical intervention were reported.
Additional Manufacturer Narrative
A visual inspection was performed found the tip of the driver to be fractured.Rotational deformation is observed just proximal to tip fracture.Device history records were reviewed for the corresponding lot and no relevant issues were identified.Complaint history record review was performed for this lot, and no similar complaints were identified.It was initially reported that the tip of the device fractured during final tightening of the screws.Follow up revealed that the device was used at a normal angle, it did not appear that excessive torque was applied, and that the patient had normal bone.Although it was reported that excessive torque did not appear to be applied, direction and degree of deformation immediately proximal to fracture indicates excessive torque was applied to device during screw final tightening.It was not reported if the torque limiting handle was used or not.The pyrenees surgical technique guide was reviewed: ¿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.¿ the most likely cause of the reported event was determined to be due to excessive torque applied during final tightening.
Event or Problem Description
It was reported that the tip of the pyrenees non-tapered torque driver broke off into the screw head intra-operatively, during final tightening.The fractured component was left in the screw.The procedure was completed successfully without surgical delay.No adverse consequences nor medical intervention were reported.

• 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: 12884073
• Report Number: 3004774118-2021-00371
• Device Sequence Number: 4802727
• 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): 03/02/2022

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: 11/18/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 11/29/2021
• Supplement Report FDA Received Date: 03/02/2022
• 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