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

Model Number	4508-90075
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that three cayman awls were bent intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report captures the third awl.
Additional Manufacturer Narrative
The device was visually inspected and the tip was confirmed to be deformed.The damage is consistent with excess force being applied most likely against bone which would have caused the tip to deform.A review of complaint history associated with the subject catalog and lot number was performed, and no adverse trends were observed.This failure indicates excess force was applied to the device which is consistent with the rep's statement that more than normal force was applied during the procedure.
Event or Problem Description
It was reported that three cayman awls were bent intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report captures the third awl.

• 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: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 14255776
• Report Number: 3004774118-2022-00169
• Device Sequence Number: 14696456
• Product Code: LXH
• UDI-Device Identifier: 10888857095526
• UDI-Public: 10888857095526
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2022

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 Model Number: 4508-90075
• Device Catalogue Number: 4508-90075
• Device Lot Number: PHFM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 07/25/2022
• 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