MAUDE Adverse Event Report: K2M, INC. SCREW INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	7601-90003
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot unknown (2): devices not yet returned.Lot kfjx (2): manufacturing date 06 january 2020, devices returned 14 april 2022 the returned devices were was inspected visually and functionally.Visual inspection revealed wear consistent with regular use of the device but did not reveal any significant deformation or damage.Functional inspection during bench testing could not replicate the described failure mode.The inserter and a model screw were assembled; the hexalobe fit into the screw without difficulty.The screw was inserted into a model bone.After the screw was fully inserted into the model bone, the inserter was disengaged from the screw without difficulty.A conclusive root cause could not be determined with the available information.Factors which may have contributed to the event include the use of excessive force, use of the device at a difficult angle, hard bone quality of the patient, and general device wear.
Event or Problem Description
This record is a consolidation of q2 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures four instances of intraoperative yukon screw inserter coupling issues.In all instances, the procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
Lot unknown (2): devices not returned.Lot kfjx (2): manufacturing date 06 january 2020, devices returned 14 april 2022.
Event or Problem Description
This record is a consolidation of q2 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures four instances of intraoperative yukon screw inserter coupling issues.In all instances, the procedure was completed successfully with no surgical delay and no adverse consequence to the patient.

• Brand Name: SCREW INSERTER
• 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: 15135848
• Report Number: 3004774118-2022-00302
• Device Sequence Number: 5196479
• Product Code: LXH
• UDI-Device Identifier: 10888857352605
• UDI-Public: 10888857352605
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 4
• Summary Report (Y/N): Y
• 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): 10/25/2022

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 Model Number: 7601-90003
• Device Catalogue Number: 7601-90003
• 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: 07/01/2022
• Supplement Date Received by Manufacturer: 10/01/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 10/25/2022
• 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