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

Catalog Number	8801-90006
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of an ozark spring loaded awl was noticed to be bent pre-operatively.No surgical delay nor adverse consequences were reported.
Event or Problem Description
It was reported that the tip of an ozark spring loaded awl was noticed to be bent pre-operatively.No surgical delay nor adverse consequences were reported.
Additional Manufacturer Narrative
A visual inspection was performed which confirmed that the tip of the inner shaft of the awl is blunt and deformed.The most distal tip of awl is bent towards one side, indicating that deformation most likely did not occur during normal, axial loading usage.Device history records were reviewed for the corresponding lot and no relevant issues were identified.Complaint history record review was performed for this lot, and no similar complaints were identified.It was reported that the tip of the device was found to be bent and blunt outside the or.Upon follow up it was reported that event was noticed during plating and that excessive force was not used.The ozark surgical technique and device ifu were reviewed: ¿the spring loaded awl will achieve fixed screw angulations only.Insert the distal end of the spring loaded awl into the desired screw hole so that it is seated on the plate.Use downward pressure to puncture the cortex of the vertebral body.The spring loaded awl will protrude into the bone up to 10 mm below the plate.¿ ¿the life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.Great care must be taken of the instruments to ensure that they remain in good working order.Instruments should be examined for wear or damage by doctors and staff in operating centers prior to surgery.¿ the most likely cause of the reported event was determined to be due to accidental impact/drop outside of the or.

• Brand Name: SPRING LOADED AWL
• 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: 12751094
• Report Number: 3004774118-2021-00350
• Device Sequence Number: 14564462
• Product Code: LXH
• UDI-Device Identifier: 10888857369283
• UDI-Public: 10888857369283
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/08/2022

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: 8801-90006
• Device Lot Number: KTHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2020
• 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