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

Model Number 6134.0185

Device Problem Material Fragmentation (1261)

Patient Problem Spinal Column Injury (2081)

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 339394441
• Report Number: 3004142400-2024-00062
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00889095178289
• UDI-Public: 00889095178289
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D154976
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6134.0185
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other