MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, CORKSCREW FT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	SUTURE ANCHOR, CORKSCREW FT
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a rotator cuff repair surgery the implant fell out of the prepared place in the bone.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
Correction: d2a, d2b.Additional info: d9, g3, h3, h6.Complaint allegation is confirmed.Visual inspection identified the anchor's threads and the square fixture of the suture anchor, corkscrew® ft with two #0 fiberwire®, each with two diamond point needles, and guide wire 3.5 x 10 mm had warped and chipped.Blue suture was frayed.Functional testing was not performed due to the damage to the device.The method of bone preparation and the quality of the bone encountered were not specified.Dfu-0087-eo precautions 3.Make sure to use the recommended drill bit or punch to create the bone socket.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: SUTURE ANCHOR, CORKSCREW FT
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: 22202558
• Report Number: 1220246-2025-02428
• Device Sequence Number: 15384184
• Product Code: MBI
• UDI-Device Identifier: 00888867022614
• UDI-Public: (01)00888867022614(11)221021(17)270930(10)15014631
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 08/28/2025

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, CORKSCREW FT
• Device Catalogue Number: AR-1915FT-1
• Device Lot Number: 15014631
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2022
• 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