MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCH BIOCOMP CORKSCREW FT VENTED; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTURE ANCH BIOCOMP CORKSCREW FT VENTED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hand surgery the implant broke during insertion.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 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
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-1927bcnf-1, corkscrew®, batch 15434972, was received for investigation.Visual inspection noted that the device was with the sutures and needles attached.The anchor had evidence of damage at the distal end.Functional testing was not performed due to the damage to the device.The method used to prepare the bone, as well as 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, or prying/leveraging the device during insertion.The complaint allegation is confirmed.

• Brand Name: SUTURE ANCH BIOCOMP CORKSCREW FT 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: 23379645
• Report Number: 1220246-2025-04810
• Device Sequence Number: 8899809
• Product Code: MAI
• UDI-Device Identifier: 00888867096868
• UDI-Public: (01)00888867096868(11)250512(17)290430(10)15434972
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082810
• 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): 01/02/2026

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: SUTURE ANCH BIOCOMP CORKSCREW FT VENTED
• Device Catalogue Number: AR-1927BCNF-1
• Device Lot Number: 15434972
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2025
• 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