MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, BIO-CORKSCREW FT; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTURE ANCHOR, BIO-CORKSCREW FT
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged ar-1927bcf-1 batch 15416174 was received for evaluation.Visual inspection revealed that the screw/implant was cracked twice.A functional test was performed by moving the suture inside the shaft, and no resistance was found.The most likely cause of the reported and observed failure is a user error.Including improper bone preparation, excessive force, and/or misalignment of the insertion.
Event or Problem Description
It was reported that during a rotator cuff repair surgery the suture did not slide properly.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 16-dec-2025: it was further noted during the device investigation that the anchor broke.

• Brand Name: SUTURE ANCHOR, BIO-CORKSCREW FT
• 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: 23957934
• Report Number: 1220246-2026-00045
• Device Sequence Number: 17549392
• Product Code: MAI
• UDI-Device Identifier: 00888867096783
• UDI-Public: (01)00888867096783(11)250407(17)290331(10)15416174
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/05/2026

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: SUTURE ANCHOR, BIO-CORKSCREW FT
• Device Catalogue Number: AR-1927BCF-1
• Device Lot Number: 15416174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown