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

Model Number	201-90133
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of a pyrenees non-tapered torque driver broke off in the screw intra-operatively.The tip was retrieved, another driver was used, and surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
A visual inspection was performed and the driver was observed to be fractured at the tip, the fracture indicated an excessive torsional force.Device history records were reviewed for the corresponding lot and no relevant manufacturing issues were identified.A review of complaint history associated with the subject lot and catalog number was performed and no adverse trends were observed.It was reported that a pyrenees torque driver tip fractured intra-operatively which was confirmed via visual inspection.The driver was observed to be fractured at the tip as the hexalobe appeared to be deformed and twisted at an angle of 30-60 degrees.Based on the fracture the failure mode indicates excessive torsional force applied on the driver.In previous correspondence with a rep it is referenced that the surgeon uses different drivers at least 2-3 days a week with 2-3 cases a day which may indicate wear and tear for this instrument could be the cause of the deformation.Based on all the available information the most likely root cause of the event is multifunctional one being excessive torsional force and the other being wear through frequent use.
Event or Problem Description
It was reported that the tip of a pyrenees non-tapered torque driver broke off in the screw intra-operatively.The tip was retrieved, another driver was used, and surgery was successfully completed with no delay.No adverse consequences or 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: 13976468
• Report Number: 3004774118-2022-00123
• Device Sequence Number: 4984833
• 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): 06/29/2022

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 Model Number: 201-90133
• Device Catalogue Number: 201-90133
• Device Lot Number: NJUA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/02/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 06/29/2022
• 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