MAUDE Adverse Event Report: GLOBUS MEDICAL, INC.; 4.0MM RETAINING HEX SIJ DRIVER

Model Number	639.650
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was unavailable for evaluation.A portion of the driver tip remains in the patient.Visual observations from the intra-op images provided reveal no unusual external markings, but a detailed evaluation could not be completed without the instrument.This evaluation determined that this failure was within expected risk; therefore, no further actions will be taken at this time.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that during surgery the tip of the driver was broken and left in the patient post operatively. this event occurred in the united kingdom.

• Common Device Name: 4.0MM RETAINING HEX SIJ DRIVER
• 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: 20354224
• Report Number: 3004142400-2024-00222
• Device Sequence Number: 15089585
• Product Code: LXH
• UDI-Device Identifier: 00849044075007
• UDI-Public: 00849044075007
• 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): 10/02/2024

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: 639.650
• Device Lot Number: FAY350CC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 10/02/2024
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male