MAUDE Adverse Event Report: ARTHREX, INC. Ø8X 30MM BC IF SCRW, VENTED; BIO SOFT TISSUE FIXATN FASTNR

Model Number	Ø8X 30MM BC IF SCRW, VENTED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint allegation is confirmed based on photographic evidence showing a fractured ar-4030c-08 bio-tenodesis¿ screw, batch 15308471.Based on the information provided¿which may include the returned device (if available), photographs, videos, the event description, and any additional field input¿arthrex has evaluated the reported event and identified the most likely contributing factors.The method of bone preparation performed during the procedure, as well as the bone quality encountered at the surgical site, was not provided and therefore could not be evaluated.The reported screw fracture during graft fixation is most likely attributable to procedural or use-related factors, which may include inadequate bone preparation, off-axis or misaligned insertion, and/or excessive bending or levering forces applied to the device during insertion.Per dfu-0111-eo, revision 3, the following contraindications and precautions are applicable and may be relevant to the reported event: for bio-tenodesis¿ screws only, screw sizes smaller than 7 mm may not be appropriate for knee indications.Use in the presence of insufficient quantity or quality of bone may compromise fixation.Blood supply limitations or previous infections may retard healing.Foreign body sensitivity may occur; appropriate testing should be performed when suspected and sensitivity ruled out prior to implantation.Foreign body reactions may occur (see adverse effects, allergic-type reactions).The device is contraindicated in the presence of active infection or blood supply limitations.Conditions that limit a patient¿s ability or willingness to comply with postoperative activity restrictions may affect clinical outcomes.The device may not be suitable for patients with insufficient or immature bone; bone quality should be carefully assessed.Implantation must not bridge, disturb, or disrupt the growth plate in skeletally immature patients.The device must only be used for the indicated surgical procedures.
Event or Problem Description
It was reported that during an anterior cruciate ligament surgery the screw broke while the graft was fixated.All fragments were retrieved from the patient.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with another screw.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: Ø8X 30MM BC IF SCRW, VENTED
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 24198417
• Report Number: 1220246-2026-00330
• Device Sequence Number: 5430929
• Product Code: MAI
• UDI-Device Identifier: 00888867277656
• UDI-Public: (01)00888867277656(11)240828(17)280731(10)15308471
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K202535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/28/2026

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: Ø8X 30MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4030C-08
• Device Lot Number: 15308471
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/08/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2024
• 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
• Patient Sex: Unknown