MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. N/A; LOCKING CAP DRIVER

Model Number	6134.0185
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available as it remains in the patient.It was reported that the creo mis locking cap driver tip sheared off.It cannot be confirmed what step during the procedure the fracture occurred during because surgical conditions cannot be replicated.Because of this, it cannot be determined if the fracture was caused by excessive forces or surgical misuse.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 locking cap driver broke off and was retained in the patient post operatively.
Additional Manufacturer Narrative
The device was returned for evaluation.It was reported that the creo mis locking cap driver tip sheared and was left in the patient.The deformation to the driver tip past the fracture point is consistent with clockwise torsional forces, meaning the tip was deformed during tightening.This is evidence of excessive force on the driver tip.Because it was not confirmed at what stage of the procedure the locking cap driver was being used for, 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 locking cap driver broke off and was retained in the patient post operatively.

• Brand Name: N/A
• Common Device Name: LOCKING CAP 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: 19043339
• Report Number: 3004142400-2024-00062
• Device Sequence Number: 8472163
• Product Code: LXH
• UDI-Device Identifier: 00889095178289
• UDI-Public: 00889095178289
• 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
• 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): 05/13/2024

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: 6134.0185
• Device Lot Number: EFX093BB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2020
• 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