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	11/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two pyrenees non-tapered torque drivers broke, and the pyrenees torque limiting handle was suspected to be out of calibration intra-operatively.The procedure was completed successfully without surgical delay.No adverse consequences occurred.This record captures the first of the two pyrenees non-tapered torque drivers.
Event or Problem Description
It was reported that two pyrenees non-tapered torque drivers broke, and the pyrenees torque limiting handle was suspected to be out of calibration intra-operatively.The procedure was completed successfully without surgical delay.No adverse consequences occurred.This record captures the first of the two pyrenees non-tapered torque drivers.
Additional Manufacturer Narrative
A visual inspection was performed which confirmed tip fracture of driver.Rotation deformation is observed immediately proximal to fracture surface.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.Initial report states that two drivers fractured and that the associated torque limiting driver may be off calibration.The rotation deformation observed indicates that fracture occurred during tightening of screws and that excessive torque was most likely applied to driver.A functional inspection was performed on the torque limiting handle and found the torque limit to be out of spec.The most likely cause of the reported event was determined to be due to the associated torque limiting handle being out of specification.Devices age may have contributed to event.

• 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: 12962501
• Report Number: 3004774118-2021-00388
• Device Sequence Number: 19270361
• Product Code: LXH
• UDI-Device Identifier: 10888857030244
• UDI-Public: 10888857030244
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/15/2022

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
• 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: 11/11/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2017
• 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: Male