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

Model Number	8801-90074
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of an ozark screwdriver broke off intra-operatively.The tip was left inside the patient.The procedure was completed successfully with a 10 minute surgical delay.
Additional Manufacturer Narrative
Visual inspection confirms the tip of the driver is fractured.Rotational deformation is observed just proximal to the tip fracture.Direction and degree of deformation proximal to the fracture indicates excessive torque was most likely applied to the driver during screw insertion.Device history records were reviewed for this lot number, no relevant manufacturing issues were identified.This device was manufactured in 2019 making it over 3 years old.Complaint history records were reviewed for this catalog number, no adverse trends were identified.It was reported via follow up communication that the tip fractured in the screw head and was not removed.There was no harm to the patient and there is no plan to revise the patient.The patient had normal bone quality and the green ratcheting handle was used with the driver.The handle used, which can mate with the ozark driver, is not from the ozark system.However, it is unlikely that the use of this handle contributed to the event as the green (pyrenees) and blue (ozark) handles are both spin-top handles that are not torque-limiting.The most likely cause of the reported event was determined to be excessive torque applied during screw insertion.The age of the device may have potentially contributed to the event, as the device was just over 3 years old at the time of the reported event.
Event or Problem Description
It was reported that the tip of an ozark screwdriver broke off intra-operatively.The tip was left inside the patient.The procedure was completed successfully with a 10 minute surgical delay.

• Brand Name: TAPERED 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: 14474762
• Report Number: 3004774118-2022-00205
• Device Sequence Number: 17439772
• Product Code: LXH
• UDI-Device Identifier: 10888857404120
• UDI-Public: 10888857404120
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 08/23/2022

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: 8801-90074
• Device Catalogue Number: 8801-90074
• Device Lot Number: HVAM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2019
• 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