MAUDE Adverse Event Report: ARTHREX, INC. BIOCOMPOSITE INTER- FERENCE SCREW; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIOCOMPOSITE INTER- FERENCE SCREW
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
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 an anterior cruciate ligament reconstruction surgery when the implant box was opened it was noticed the threads on the screw were not there.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.Update 18-dec-2025: during an initial inspection of the returned device at arthrex gmbh it was noticed that the device has signs of usage and was likely used in the patient.Further information requested.
Additional Manufacturer Narrative
Additional information: b5, d9, g3.
Event or Problem Description
Update 13-jan-2026: it was confirmed that the surgeon attempted to use the implant but it failed to hold.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Visual inspection of the biocomposite interference screw, with disposable sheath, 10 x 23 mm, identified that the threads were damaged.Functional testing was not performed due to the damage to the device.The method of bone preparation and the quality of the bone encountered were not specified.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.However, the device was returned without packaging components, and we are unable to confirm whether it was damaged before opening the package.

• Brand Name: BIOCOMPOSITE INTER- FERENCE SCREW
• 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: 23977115
• Report Number: 1220246-2026-00082
• Device Sequence Number: 4786607
• Product Code: MAI
• UDI-Device Identifier: 00888867016163
• UDI-Public: (01)00888867016163(11)231030(17)270930(10)15160719
• Combination Product (Y/N): N
• Initial Reporter Country: KE
• 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,Followup
• Report Date (Section B): 02/25/2026

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: BIOCOMPOSITE INTER- FERENCE SCREW
• Device Catalogue Number: AR-1400C
• Device Lot Number: 15160719
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 01/13/2026; 02/24/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 01/20/2026; 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown