MAUDE Adverse Event Report: GLOBUS MEDICAL, INC.; DRIVER SHAFT, 1/4 INCH QUICK-CONNECT, SHORT

Model Number	6067.0050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation.It was reported that a "driver shaft, 1/4" quick-connect, short" driver was broken into multiple pieces intra-operatively during final tightening and may have be left within the patient post-operatively.It was revealed the fractured instrument related to the event was unavailable at the time of this writing.An image provided by the reporter showed the tip fragments recovered from the surgical site and the fractured driver.Although tip fracture is consistent with excessive forces applied to the instrument, operative conditions are unable to be replicated, therefore no determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that during a surgery that the tip of the driver was broken into multiple pieces, and parts may be left in the patient post operatively. .
Additional Manufacturer Narrative
The device was available for evaluation.A single driver (6067.0050) was returned for evaluation with the tip fractured off.The reported fracture is consistent with excessive force.Due to the inability to replicate operative conditions, no determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that during a surgery that the tip of the driver was broken into multiple pieces, and parts may be left in the patient post operatively. .

• Common Device Name: DRIVER SHAFT, 1/4 INCH QUICK-CONNECT, SHORT
• 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: 19309758
• Report Number: 3004142400-2024-00087
• Device Sequence Number: 17870452
• Product Code: LXH
• UDI-Device Identifier: 00889095167948
• UDI-Public: 00889095167948
• 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,Followup
• Report Date (Section B): 06/26/2024

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: 6067.0050
• Device Lot Number: ADA104CE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2022
• 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: Female