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 second awl.
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 second awl.
Additional Manufacturer Narrative
The awl was visually inspected and it was confirmed that the tip was bent which is consistent with excess force being applied at an odd angle.Device history records were reviewed for this lot, and no relevant manufacturing issues were identified.Complaint history records were reviewed for this lot and catalog number, similar complaints were identified as the device associated with this report was over 3 years old at the time of the incident, it is likely that repeated use over the device's lifetime led to the tip deformation.

• 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: 14255475
• Report Number: 3004774118-2022-00167
• Device Sequence Number: 11960746
• 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: Other
• 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: JCPC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2022
• Is the Reporter a Health Professional?: No
• 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
• Date Device Manufactured: 03/29/2019
• 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