MAUDE Adverse Event Report: ICOTEC AG KONG-TL VBR SYSTEM, SCREWDRIVER FOR LOCKING SCREW

Model Number	44-050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Production documentation of the screwdriver has been checked, no anomalies were detected when the screwdriver was released to the market.The screwdriver has been returned from the hospital.A fracture pattern analysis has been initiated.A follow-up report will be submitted if additional relevant information becomes known.
Event or Problem Description
During the loan container inspection at the manufacturer it was noticed that the tip of a screwdriver was broken off.It is assumed that the fragment has broken off during the last surgery.It can not be excluded that the broken off fragment remained in the head of the locking screw and therefore in the patient's body.The suitability of the material of the fragment (stainless steel 1.4112) has not been evaluated for long-term tissue/bone contact.Undesirable local or systemic effects cannot be excluded.

• Brand Name: KONG-TL VBR SYSTEM, SCREWDRIVER FOR LOCKING SCREW
• Common Device Name: KONG-TL VBR SYSTEM, SCREWDRIVER FOR LOCKING SCREW
• Manufacturer (Section D): ICOTEC AG; industriestrasse 12; altstaetten, sg 9450 ; SZ 9450
• Manufacturer (Section G): ICOTEC AG; industriestrasse 12; altstaetten, sg 9450 ; SZ 9450
• Manufacturer Contact: joerg schneider ; industriestrasse 12; altstaetten, sg 9450 ; SZ 9450
• MDR Report Key: 22860250
• Report Number: 3006493760-2025-00004
• Device Sequence Number: 15787621
• Product Code: MQP
• UDI-Device Identifier: 07640164847849
• UDI-Public: 07640164847849
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K232790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2025

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
• Device Model Number: 44-050
• Device Lot Number: 23/01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown