MAUDE Adverse Event Report: TAG MEDICAL PRODUCT CORPORATION LTD FLEX.GUIDE PIN STERILE (5 U.SET)

Model Number	234-108-200
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our investigation team, which consists of engineering, production, qc and qa personals performed the investigation and this is their finding.See ifu # ifu108st with the necessary information provided for the use of this device.All the processes in tag for the manufacture and design of this device are validated and approved.The record in the dhf complies with all the requirements and the device was not returned for investigation.After reviewing the ifu information - description of the complaint - and dhf information our investigation team concluded that the ifu instructions were not followed and that is the reason the pin breakage and left in the patient's bone.Root cause: ifu instructions not followed.
Event or Problem Description
Event description: sales rep report: a versitomic pin was reported to have broken inside the femur of a patient during acl surgery.

• Brand Name: FLEX.GUIDE PIN STERILE (5 U.SET)
• Common Device Name: FLEX.GUIDE PIN STERILE (5 U.SET)
• Manufacturer (Section D): TAG MEDICAL PRODUCT CORPORATION LTD; gaaton 2513000,isr; gaaton, isreal ; IS
• MDR Report Key: 21932811
• Report Number: 8043971-0201-02024
• Device Sequence Number: 15652491
• Product Code: FZX
• UDI-Device Identifier: 10810190018924
• UDI-Public: 10810190018924
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/11/2024

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: 234-108-200
• Device Catalogue Number: 234-108-200
• Device Lot Number: 24D03
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2025
• Patient Sequence Number: 1
• Patient Sex: Unknown