MAUDE Adverse Event Report: K2M, INC. TAPERED DRIVER; SIZE 10; TAPERED DRIVER SIZE 10

Model Number	8801-90074
Medical Device Problem Codes	Material Deformation (2976); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an ozark tapered driver tip was found to be worn prior to surgery.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
The device was visually inspected.The tip is worn and while the wear is minor, the very edges of the hexalobe star are worn off.Functionally, the device is able to engage and hold screws but the connection is not stable.Device history records were reviewed for this lot, and no relevant manufacturing issues were identified.A review of complaint history associated with the subject catalog and lot number was performed, and no adverse trends were observed.It was further reported via follow up communication that the tip is deformed and no longer holds the screws and is stripping them.The device is used weekly and excessive force was not applied.It is likely that the minor wear/deformations observed is causing the driver to not properly sit flush in the screws, causing them to strip.The most likely cause of the reported event was determined to be due to wear from normal use.Excessive force may have contributed to the event, however no rotational deformation is observed so it is unlikely.Weekly use of the device over 1 year can result in the minor wear observed, especially if used on larger constructs which require multiple uses per case.
Event or Problem Description
It was reported that an ozark tapered driver tip was found to be worn prior to surgery.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.

• Brand Name: TAPERED DRIVER; SIZE 10
• Common Device Name: TAPERED DRIVER SIZE 10
• 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: 14780196
• Report Number: 3004774118-2022-00249
• Device Sequence Number: 17367252
• Product Code: LXH
• UDI-Device Identifier: 10888857404120
• UDI-Public: 10888857404120
• 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): 09/09/2022

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: NYXB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2021
• 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