MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. N/A; 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	02/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor any images were available for evaluation as the device remains in the patient.Upon evaluation of the information provided, it was reported that the tip of one 1.6mm k-wire , 500mm, blunt tip broke off during a posterior fusion on levels l5-s1 on (b)(6) 2024 and remains in the patient.Neither the k-wire nor post-op images were returned so visual confirmation that the distal tip has fractured could not be completed.No information pertinent to the k-wire fracture has been provided, therefore, the exact surgical conditions cannot be replicated and no determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that during a case the tip of the k-wire broke off and was retained in the vertebral body post operatively.

• Brand Name: N/A
• 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: 18767314
• Report Number: 3004142400-2024-00041
• Device Sequence Number: 7795177
• 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: 2024
• 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): 02/22/2024

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: 02/02/2024
• Initial Report FDA Received Date: 02/23/2024
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown