MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. N/A; PEDICLE PROBE, THORACIC, STRAIGHT

Model Number	624.114
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the tip of the instrument broke off inside the patient pedicle as it was being removed, and was left in the patient post operatively.This event occurred in australia. .
Additional Manufacturer Narrative
The part was available for evaluation.Upon initial evaluation it was found that the pedicle probe fractured approximately 25mm from the tip, and had a slight bend from the broken edge to about the 40mm mark (see attached image).The 30mm etchings were also rotated out of alignment with the rest of the depth etchings, but it is not known if this is a result of the material twisting, or if the etching was out of alignment initially.The tip was left in the patient and was not returned for evaluation.A dimensional inspection could not be performed due to the fractured and bent tip and a functional inspection was not performed as surgical conditions could not be replicated.This is a known inherent risk of this instrument.No determinations could be made as to the cause of the reported issue.

• Brand Name: N/A
• Common Device Name: PEDICLE PROBE, THORACIC, STRAIGHT
• 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: 18617847
• Report Number: 3004142400-2024-00015
• Device Sequence Number: 20694092
• Product Code: LXH
• UDI-Device Identifier: 00849044055481
• UDI-Public: 00849044055481
• 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: 2023
• 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): 01/30/2024

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: 624.114
• Device Lot Number: FAS341DB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2015
• 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