MAUDE Adverse Event Report: K2M, INC. UNIVERSAL DRILL; SIZE Ø5.5X20 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	2008-90051
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of a chesapeake al universal drill fractured off intra-operatively.The fractured tip was removed from the patient and the procedure was completed successfully with less than a one minute surgical delay and no adverse consequences to the patient.
Event or Problem Description
It was reported that the tip of a chesapeake al universal drill fractured off intra-operatively.The fractured tip was removed from the patient and the procedure was completed successfully with less than a one minute surgical delay and no adverse consequences to the patient.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.Additional data: d4, d9, h3, h4.

• Brand Name: UNIVERSAL DRILL; SIZE Ø5.5X20 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: 20176356
• Report Number: 3004774118-2024-00072
• Device Sequence Number: 12827228
• Product Code: LXH
• UDI-Device Identifier: 10888857025684
• UDI-Public: (01)10888857025684(11)201104(10)MXNP
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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: 2008-90051
• Device Lot Number: MXNP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2020
• 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