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

Model Number	8801-90034
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
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 during removal of a plate two ozark screwdrivers became broken and unusable at the tip.This report captures the second screwdriver.
Additional Manufacturer Narrative
Visual inspection was performed.The tip of the driver is fractured.All points of the hexalobe are highly rotated just proximal to the fracture.Complaint history records were reviewed for this catalog number, no adverse trends were identified.It was reported via follow up communication that the or team could not remove a femoral plate.So they suggested using the ozark drivers.The drivers were damaged as they were used off-label on a different system that is not compatible with ozark drivers.The brand and femoral plate type is unknown.The most likely root cause was determined to be off-label use of the drivers to remove femoral plate screws.Ozark drivers are intended for ozark acdf screws only.
Event or Problem Description
It was reported that during removal of a plate two ozark screwdrivers became broken and unusable at the tip.This report captures the second screwdriver.

• 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: 14522142
• Report Number: 3004774118-2022-00210
• Device Sequence Number: 12369358
• Product Code: LXH
• UDI-Device Identifier: 10888857400863
• UDI-Public: 10888857400863
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 8801-90034
• Device Catalogue Number: 8801-90034
• Device Lot Number: MPRU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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