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	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.It was reported that the tip of a 1.6mm nitinol k-wire, 500mm, blunt tip was broken in situ and left in the patient.It was reported that the surgery was a posterior fusion of l4-s1, however the returned images looked like a fusion of l4-l5 with an interbody with integrated screws.In these images, the k-wire tip was seen protruding from the l5 left screw.The wire was at a steep angle that went medial and proximal to the screw trajectory.As this angle is deviated from the path of the screw, it is possible that while inserting the screw the k-wire was driven fuhrer into the pedicle off trajectory.When trying to remove it, this deviation can create a stress point in the wire that could fracture when the force of removal is applied to it.However the surgical conditions cannot be replicated or confirmed by the rep, so the cause cannot be established.There was another returned ap image of a construct of 2 consecutive interbodies and posterior fusion of l3-l5 where there was something seen protruding from the screw in right l3, however it could not be confirmed what was seen protruding based on the imaging.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 patient post operatively.This event occurred in panama.

• 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: 18849842
• Report Number: 3004142400-2024-00047
• Device Sequence Number: 20697492
• 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): 02/21/2024

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: 02/07/2024
• Initial Report FDA Received Date: 03/06/2024
• 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: Male