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

Model Number	8801-90034
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that the tip of an ozark screwdriver fractured.The reported event was noted during inspection.There is no procedure associated with this reported event, no patient involvement, and no adverse consequence has been reported.
Additional Manufacturer Narrative
A visual inspection confirmed the reported issue of tip fracture.The threaded inner shaft tip was observed to be fractured off.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.A definitive root cause could not be determined.Potential root causes include: not using torque limiting handle, excessive force, and hard bone density.
Event or Problem Description
A company representative reported that the tip of an ozark screwdriver fractured.The reported event was noted during inspection.There is no procedure associated with this reported event, no patient involvement, and no adverse consequence has been reported.

• 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: 14021741
• Report Number: 3004774118-2022-00130
• Device Sequence Number: 6136440
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2022

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: JKKY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2022
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2019
• 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