MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP INTERFSCRW W/DISP SHTH; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP INTERFSCRW W/DISP SHTH
Medical Device Problem Codes	Dull, Blunt (2407); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a knee surgery the screw was dull and could not be inserted.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-1370c biocomposite interference screw, batch 15403529, was received for investigation.Visual evaluation revealed that the threads of the screw are stripped and damaged, making it difficult to penetrate the bone.Functional testing was not performed due to the device's damage.Information regarding the method used to prepare the bone and the bone quality encountered during the procedure was not provided.The most likely cause can be attributed to: -misuse due to improper bone preparation.-misaligned insertion.-prying or leveraging the screw during insertion.Per dfu-0111-eo; revision 2; section g ¿ precautions: 6.¿bio-absorbable interference screw only: it is important to completely seat the screwdriver to prevent potential stripping of the hex and/or screw fracture during insertion or removal.¿ 7.¿bio-absorbable interference screw only: if inserting the interference screw through the anteromedial portal, a knee flexion angle of 120° must be maintained throughout the entire insertion process.Not maintaining or changing the knee flexion angle during screw insertion may result in screw divergence or failure of the screwdriver.¿ refer to the attached investigation photos.The complaint allegation that the screw became dull/lost its geometry is confirmed.

• Brand Name: BIO-COMP INTERFSCRW W/DISP SHTH
• 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: 22236285
• Report Number: 1220246-2025-02484
• Device Sequence Number: 15498009
• Product Code: MAI
• UDI-Device Identifier: 00888867014633
• UDI-Public: (01)00888867014633(11)250312(17)290131(10)15403529
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071176
• 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,Followup
• Report Date (Section B): 11/24/2025

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
• Operator of Device: Health Professional
• Device Model Number: BIO-COMP INTERFSCRW W/DISP SHTH
• Device Catalogue Number: AR-1370C
• Device Lot Number: 15403529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 05/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown