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 Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
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 a rotator cuff repair surgery the anchor broke.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
Additional information: d9, g3, h3, h6.One unpackaged ar-1927bc corkscrew® (batch 15451890) was received for evaluation.Visual inspection identified that the device was returned with the sutures but without the anchor.Functional testing was not performed due to the condition of the returned device.The most likely cause for the reported failure can be attributed to use-related factors, such as misaligned insertion, improper bone preparation, or prying/leverage applied with excessive force.The complaint allegation that the anchor was fractured is not confirmed, as the device was returned incomplete.

• 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: 23427297
• Report Number: 1220246-2025-04906
• Device Sequence Number: 9853813
• Product Code: MAI
• UDI-Device Identifier: 00888867023352
• UDI-Public: (01)00888867023352(11)250616(17)290531(10)15451890
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061863
• 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 Model Number: SUTURE ANCHOR, BIO-CORKSCREW FT
• Device Catalogue Number: AR-1927BCF
• Device Lot Number: 15451890
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 10/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown