MAUDE Adverse Event Report: TAG MEDICAL PRODUCTS CORPORATION LTD BETTA LINK IMPLANT SHOULDER BSM

Model Number	110045149
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the betta link 2.9 shoulder knotless anchors used in a brostrom surgery were inserted into the fibula.2 anchors both with different lots stayed in the bone and the eyelet broke releasing the sutures.The surgeon was not able to remove part of one of the anchors and it remains in the patient's bone.
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 180bsm, with the necessary information provided for the use of this device.Also note that in the warning it is stated not to use excessive tension or overload the device this could lead to device breakage.Also, in the information for use notes number 3 ask for the use of a guide - note 5 ask for maintaining the location of the hole - notes 6-7-8 explains the proper use of the device to get the right results.Our investigation team reviewed the above information that the all the of this device were validated and approved - the dhf complies to quality requirements concluded that ifu instructions were not followed and there was misuse of the device that cause this failure.Root cause: misuse of the device.

• Brand Name: BETTA LINK IMPLANT SHOULDER BSM
• Common Device Name: BETTA LINK IMPLANT SHOULDER BSM
• Manufacturer (Section D): TAG MEDICAL PRODUCTS CORPORATION LTD; gaaton 2513000,isr; gaaton,isreal,isr; gaaton, ; IS
• MDR Report Key: 21975282
• Report Number: 8043971-0187-02024
• Device Sequence Number: 9197836
• Product Code: HXI
• UDI-Device Identifier: 10818674025789
• UDI-Public: 10818674025789
• 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): 10/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 110045149
• Device Lot Number: 23J25-- 23K46
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown