MAUDE Adverse Event Report: GLOBUS MEDICAL, INC.; 4.5MM CANNULATED TAP

Model Number	6134.0045
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation.It was reported that the 4.5mm cannulated tap tip sheared and was left in the patient on (b)(6) 2024.The case was stated to be a tethering case with no fusion and no additional interbodies used.The tethering was from t6 to l4.It was stated that the tap was used to create the pathway for the screw as well as read the screw length required.These steps are typical procedural steps for the cannulated tap.It cannot be confirmed what forces were placed on the tap that may have caused a fracture because surgical conditions cannot 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 case the tip of the cannulated tap broke off and was retained in the patient's vertebral body post operatively.This event occurred in hong kong.
Additional Manufacturer Narrative
The device was available for evaluation.It was reported that the 4.5mm cannulated tap tip sheared and was left in the patient on (b)(6) 2024.Visual inspection of the returned tap found the tip fractured and confirmed the reported issue.This type of damage is consistent with excessive stress, however because surgical conditions cannot be replicated, and 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 cannulated tap broke off and was retained in the patient's vertebral body post operatively.This event occurred in hong kong.

• Common Device Name: 4.5MM CANNULATED TAP
• 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: 19203685
• Report Number: 3004142400-2024-00077
• Device Sequence Number: 7927427
• Product Code: LXH
• UDI-Device Identifier: 00889095178104
• UDI-Public: 00889095178104
• 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): 06/13/2024

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: 6134.0045
• Device Lot Number: TLY202AB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2021
• 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
• Patient Race: Asian