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

Catalog Number	2008-90029
Medical Device Problem Code	Material Deformation (2976)
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 a chesapeake al drill deformed intra-operatively.The procedure was completed successfully with no surgical delay and no adverse consequences to the patient.
Event or Problem Description
It was reported that a chesapeake al drill deformed intra-operatively.The procedure was completed successfully with no surgical delay and no adverse consequences to the patient.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.

• Brand Name: 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: 20175567
• Report Number: 3004774118-2024-00073
• Device Sequence Number: 20583533
• Product Code: LXH
• UDI-Device Identifier: 10888857025547
• UDI-Public: (01)10888857025547(11)130610(10)BTBV
• 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: 2008-90029
• Device Lot Number: BTBV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• 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: 06/10/2013
• 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