MAUDE Adverse Event Report: K2M, INC. SPRING LOADED AWL; SIZE 20 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	4508-90075
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that the tip of a cayman mi spring loaded awl fractured intra-operatively.The procedure was completed successfully with no surgical delay and no adverse consequences to the patient.
Event or Problem Description
A company representative reported that the tip of a cayman mi spring loaded awl was "broken" intra-operatively.Inspection of the returned device indicates that the device tip was deformed.The procedure was completed successfully with no surgical delay and no adverse consequences to the patient.

• Brand Name: SPRING LOADED AWL; SIZE 20 MM
• 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: 20233638
• Report Number: 3004774118-2024-00079
• Device Sequence Number: 15642083
• Product Code: LXH
• UDI-Device Identifier: 10888857095526
• UDI-Public: (01)10888857095526(11)220401(10)XRJG
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 01/15/2025

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: 4508-90075
• Device Lot Number: XRJG
• 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: 08/21/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• 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