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

Model Number	201-90133
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tips of two pyrenees constrained cervical non-tapered drivers stripped 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 drivers.
Event or Problem Description
It was reported that the tips of two pyrenees constrained cervical non-tapered drivers stripped 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 drivers.
Additional Manufacturer Narrative
A visual inspection was performed and the driver was observed to deformed at the tip, the hexalobe is twisted at an angle between 30-60 degrees.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.In previous correspondence it is referenced that the surgeon uses different drivers at least 2-3 days a week with 2-3 cases a day.This may indicate that wear and tear for this instrument may be the cause of the deformation.Another possible cause for this may be excessive force as it is stated from correspondence that the surgeon applies excess force to the point of almost yielding, which indicates that the surgeon may be creating a bending moment in excess of the materials yield strength which would cause the deformation on the tip.The rep also states in the correspondence that the surgeon uses an ao static connect handle with the drivers while the surgical technique states to use a torque limiting handle.Based on all the available information the most likely cause of the event was deviation from surgical technique.

• 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: 13733429
• Report Number: 3004774118-2022-00098
• Device Sequence Number: 4994108
• 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): 06/20/2022

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: 03/03/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 06/20/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown