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

Catalog Number	4508-90075
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a hinge of cayman mi spring loaded awl is 'broken' and tip is bent intra-operatively.Piece was recovered from patient.No adverse consequences, surgical delay or medical intervention were reported.  the procedure was completed successfully.
Additional Manufacturer Narrative
Visual inspection: the device was inspected, and it was observed that the distal tip was bent.It was also observed that the dowel pin that secures the inner shaft to the outer shaft was fractured.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Per ifu: pilot hole preparation proceed to drill the pilot drill hole through the fixed, variable, or screw-thru fixed drill guide.If a power drill is required, the hudson adaptor may be used to connect the drill bit to the power drill.Awls are provided as an alternative method.Note: the variable drill guide allows for 15° of angle variation allowing placement of the screws anywhere from 15º from normal to the plate (cephalad/caudal) to normal (parallel) to the endplates.Drills and awls are used to prepare the pilot hole.Hard bone may have contributed to the failure.Repeated use over the lifetime of the instrument may have also contributed to the failure.
Event or Problem Description
It was reported that a hinge of cayman mi spring loaded awl is 'broken' and the tip bent intra-operatively.All broken fragments were recovered from patient.The procedure was completed successfully with no adverse consequences, surgical delay or medical intervention reported.

• 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: 12284914
• Report Number: 3004774118-2021-00242
• Device Sequence Number: 5403199
• 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): 11/18/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 11/19/2021
• 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