MAUDE Adverse Event Report: GLOBUS MEDICAL, INC.; 1.6MM NITINOL K-WIRE, 500MM, BLUNT TIP

Model Number	685.007
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation as it remains in the patient.Upon evaluation of the information provided, it was reported that (1) k-wire tip broke off during a posterior fusion on levels l1-s2ai on (b)(6)2023 and remains in the patient.The patient is an asian female with osteoporosis.It was stated that the wire was broken when removing it after inserting a large screw into the sacrum after the surgeon had elected not to tap.The k-wire was removed using pliers and a hammer.It was stated that at the time of the surgery there was no tip fracture observed.The k-wire tip was seen in a post-op image two days on (b)(6) 2023) after the procedure.The k-wire or post-op images were unavailable, so it could not be visually confirmed that the distal tip had fractured.This type of damage may have been caused from a deviation of trajectory that would cause an interference between the k-wire and instrument/implant.That interference could then place excessive force on the tip of the k-wire during removal and cause it to fracture.However, because the exact surgical conditions and trajectories cannot be replicated, no determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that during surgery the k-wire broke during removal and was found to be remain inside the patient's body post operatively.This event occurred in japan.

• Common Device Name: 1.6MM NITINOL K-WIRE, 500MM, BLUNT TIP
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 18633037
• Report Number: 3004142400-2024-00006
• Device Sequence Number: 7954585
• Product Code: LXH
• UDI-Device Identifier: 00849044072105
• UDI-Public: 00849044072105
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: D154976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2024

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: 685.007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2023
• Initial Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Race: Asian