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

Catalog Number	4508-90075
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the cayman mi spring loaded awl bent intra-operatively.The procedure was not completed successfully as the plate screws were unable to be implanted due to this event.No adverse consequences were reported at this time.
Additional Manufacturer Narrative
Visual, functional, and dimensional inspection could not be preformed as the device was not returned.However, upon review of the provided photo, it was confirmed that the distal tip was bent.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Drills and awls are used to prepare the pilot hole.Using the instrument on harder than normal bone may have compromised the integrity of the distal tip.Repeated use over the lifetime of the instrument may have also contributed to the failure.H3 other text : device not returned for evaluation.
Event or Problem Description
It was reported that the tip of the cayman mi spring loaded awl bent intra-operatively.The awl is used to prepare the bone for placement of screws.The surgeon did not elect to use or did not have on hand a back-up instrument to prepare the second screw hole.The cayman united two-hole plate and cascadia interbody were implanted but only one of two securing screws was placed.No adverse consequences to the patient have been reported and the surgeon does not plan to re-operate at this time.This record captures the deformed cayman mi spring loaded 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: 12558290
• Report Number: 3004774118-2021-00293
• Device Sequence Number: 19979484
• Product Code: LXH
• UDI-Device Identifier: 10888857095526
• UDI-Public: 10888857095526
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 01/14/2022

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 Catalogue Number: 4508-90075
• Device Lot Number: JCPC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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