MAUDE Adverse Event Report: Artelon FLEXBAND TWIST 30; Fastener, Fixation, Nondegradable, Soft Tissue

Catalog Number	TW030
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "when using a tw030 kit, upon malleating the 2nd anchor into the fibula the anchor did not bite and pulled out.When doctor pulled the flexband strip out of the tunnel the eyelet was still on the flexband strip as expected, but the screw was missing.Doctor scoped the patient and extended incision but could not locate the missing screw.Also checked trash and drapes, and floor for screw and did not locate.Screw is lost somewhere in the patients ankle, no adverse consequences yet but doc worried about it migrating into joint space.We never located the screw, its in the patients bone but cannot confirm because can¿t id on xray.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.

• Brand Name: FLEXBAND TWIST 30
• Common Device Name: Fastener, Fixation, Nondegradable, Soft Tissue
• Manufacturer (Section D): Artelon; 8601 dunwoody place; suite 250; sandy springs GA 30350
• Manufacturer (Section G): Artelon; 8601 dunwoody place; suite 250; sandy springs GA 30350
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50355994
• Report Number: 3010673515-2026-00001
• Device Sequence Number: 10112065
• Product Code: MBI
• UDI-Device Identifier: 00850003396323
• UDI-Public: 00850003396323
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K190402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/20/2026

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 Catalogue Number: TW030
• Device Lot Number: RK33319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 19 YR
• Patient Sex: Male