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 Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 6 january 2026, a distributor reported via email that ar-1380c lot 15322180 bio-comp interfscrw w/disp shth's bio-screw crack during acl procedures on 05th nov 2025.The procedure was completed successfully with an additional ar-1380c, and no patient harm was reported on patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause(s) for the reported failure can be a user error due to improper bone preparation, misaligned insertion, and/or prying/levering the device during insertion.

• 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: 24129818
• Report Number: 1220246-2026-00260
• Device Sequence Number: 20185291
• Product Code: MAI
• UDI-Device Identifier: 00888867015272
• UDI-Public: (01)00888867015272(11)240925(17)280831(10)15322180
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K071176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2026

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: BIO-COMP INTERFSCRW W/DISP SHTH
• Device Catalogue Number: AR-1380C
• Device Lot Number: 15322180
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2024
• 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