MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMPR INTERF SCRW,FULL THD; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMPR INTERF SCRW,FULL THD
Medical Device Problem Code	Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/24/2025, it was reported by an arthrex employee via (b)(4) that an ar-1403tc bio-compr interf screw was stripped during the creation of the tibial tunnel.This was discovered during the case.The case was completed by using another device with no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
The complaint device was not received for evaluation.Based on the provided information, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional field data, arthrex concluded that the most likely cause of the reported failure is user error.This includes improper bone preparation, misaligned insertion, and/or prying or levering the device during insertion, which resulted in the device breaking and/or being damaged.Since the complaint device was not returned and no evidence of the failure was provided, neither physical inspection nor a review of images could be performed.As a result, the complaint allegation could not be confirmed.
Event or Problem Description
Additional information was provided by sales rep on 03-nov-25 that this was discovered during a knee case and a ligament reconstruction with tibial osteotomy was performed.A tap was used to thread the tunnel and the bone quality of the patient was good.The implant did not break, only lost the initial thread.A graft from the flexor and fibular tendon was used, resulting in a thickness of 10mm.The surgeon chose to insert a 11x28 mm screw, which stripped, so a smaller 10x28 mm had to be used.

• Brand Name: BIO-COMPR INTERF SCRW,FULL THD
• 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: 23451475
• Report Number: 1220246-2025-04957
• Device Sequence Number: 8074205
• Product Code: MAI
• UDI-Device Identifier: 00888867016545
• UDI-Public: (01)00888867016545(11)220105(17)251231(10)14879795
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 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 Expiration Date: 12/31/2025
• Device Model Number: BIO-COMPR INTERF SCRW,FULL THD
• Device Catalogue Number: AR-1403TC
• Device Lot Number: 14879795
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown