MAUDE Adverse Event Report: K2M, INC. HEIGHT EXPANSION DRIVER; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	2112-90007
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a capri expandable height expansion driver "no longer grips the screw head" after cleaning/sterilization.There is no procedure associated with this reported event, no patient involvement, and no adverse consequence has been reported.
Event or Problem Description
It was reported that a capri expandable height expansion driver "no longer grips the screw head" after cleaning/sterilization.There is no procedure associated with this reported event, no patient involvement, and no adverse consequence has been reported.
Additional Manufacturer Narrative
Visual inspection: the tip of the driver was deformed and stripped.Device history records were reviewed for this lot and no relevant manufacturing issues were identified.Complaint history records were reviewed for this lot, similar complaints were identified.From the capri surgical technique guide: 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 as the device is five years old, wear from its extended use is the likely cause for the event.Misalignment with the mating screw and/or excessive force applied may also cause the tip to deform.

• Brand Name: HEIGHT EXPANSION DRIVER
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• 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: 12987746
• Report Number: 3004774118-2021-00390
• Device Sequence Number: 11180904
• Product Code: MPQ
• UDI-Device Identifier: 10888857033641
• UDI-Public: 10888857033641
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2022

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: 2112-90007
• Device Catalogue Number: 2112-90007
• Device Lot Number: ELDG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2016
• 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