MAUDE Adverse Event Report: K2M, INC. SCREW DRIVER W/ THREAD; SIZE 10; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	8801-90034
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the thread of an ozark threaded screw driver was 'missing' intra-operatively.The procedure was completed successfully without surgical delay.No adverse consequences nor medical intervention were reported.
Event or Problem Description
It was reported that the thread of an ozark threaded screw driver was 'missing' intra-operatively.The procedure was completed successfully without surgical delay.No adverse consequences nor medical intervention were reported.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records could not be reviewed as a valid lot number was not provided and could not be obtained.It was initially reported that the screwdriver tip was found to be fractured as it was unable to be secured to the ozark screw by threading the inner tip of the driver into the screw head.The ozark surgical technique and device ifu were reviewed: ¿note: do not over angulate screws beyond their indicated limit, doing so could result in the inability to lock the cover.Once the screw hole is prepared and the appropriately sized screw is selected, screws can be inserted into the plate using the size 10 tapered driver or the size 10 threaded driver.¿ for instruments designed for re-use: ¿the life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.Great care must be taken of the instruments to ensure that they remain in good working order.Instruments should be examined for wear or damage by doctors and staff in operating centers prior to surgery.¿ due to no product returned and no information provided from the field the root cause could not be determined conclusively.Potential root cause includes, but is not limited to, age of device (normal wear), excessive torque applied during insertion, damage from cleaning/sterilization process.

• Brand Name: SCREW DRIVER W/ THREAD; 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: 12683100
• Report Number: 3004774118-2021-00323
• Device Sequence Number: 17150696
• Product Code: LXH
• UDI-Device Identifier: 10888857400863
• UDI-Public: 10888857400863
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/25/2022

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: 8801-90034
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2021
• Supplement Date Received by Manufacturer: 12/28/2021
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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