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

Catalog 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	04/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot mfev (2): the returned devices were inspected visually and functionally.Visual inspection did not reveal any damage, deformation, or obvious signs of wear.Functional inspection during bench testing could not replicate the described failure mode.For functional testing, the inserter and a model screw were assembled; the hexalobe fit into the screw without difficulty.No jamming was observed when disengaging the inserter from the screw.Complaint history was reviewed for the reported lot number and no previous complaints were identified.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, and hard bone quality of the patient.Lot unknown (1): the device was not returned for evaluation.Device history records could not be reviewed without either the device or a valid lot number.Complaint history was reviewed for the reported catalogue number and five similar complaints were identified.The user may experience difficult disassembly of the screw inserter and screw if the hexalobe tip is deformed prior to insertion or becomes deformed during insertion, the inserter is used with complex maneuvers, or if the user is attempting to disengage the inserter in a position not coaxial to the screw shank hex (i.E., removing the device at an angle from the screw).A surgeon's technique (burying the screw, using an entry point and/or screw trajectory that places the screw head closer to the anatomy, etc.) may contribute to this failure mode as well.A conclusive root cause cannot be established.If additional information is received or the device is returned for evaluation, the investigation will be reopened and updated.
Event or Problem Description
This record is a consolidation of q1 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures three instances of intraoperative yukon screw inserter tip coupling issues (jamming).In all cases, 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: 14252895
• Report Number: 3004774118-2022-00159
• Device Sequence Number: 17397307
• 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: 3
• 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
• Report Date (Section B): 04/29/2022

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: 7601-90003
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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