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

Catalog Number	6201-90001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that the tip of a mesa 2 screw inserter fractured during surgery.The fractured tip was not located post-operatively and the operating surgeon was, "confident that the tip did not fall into the patient." the procedure was completed successfully with no surgical delay and no reported adverse consequence to the patient.
Event or Problem Description
A company representative reported that the tip of a mesa 2 screw inserter fractured during surgery.The fractured tip was not located post-operatively and the operating surgeon was, "confident that the tip did not fall into the patient." the procedure was completed successfully with no surgical delay and no reported adverse consequence to the patient.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
A company representative reported that the tip of a mesa 2 screw inserter fractured during surgery.The fractured tip was not located post-operatively and the operating surgeon was, "confident that the tip did not fall into the patient." the procedure was completed successfully with no surgical delay and no reported adverse consequence to the patient.
Additional Manufacturer Narrative
H6 coding has been updated to reflect an updated investigation conclusion following product return.

• 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: matthew kelleher ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 19652179
• Report Number: 3004774118-2024-00054
• Device Sequence Number: 6904863
• Product Code: LXH
• UDI-Device Identifier: 10888857126688
• UDI-Public: (01)10888857126688(11)200914(10)MBGR
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2025

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: 6201-90001
• Device Lot Number: MBGR
• 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: 06/19/2024
• Supplement Date Received by Manufacturer: 10/30/2024; 01/16/2025
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 11/27/2024; 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2020
• 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