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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Update swit 26-jun-2024: further information was provided that the suture of the device broke off.It broke off inside the patient but was retrieved.
Additional Manufacturer Narrative
Additional information: b5.Update swit 26-jun-2024: further information was provided that the suture of the device broke off.It broke off inside the patient but was retrieved.
Event or Problem Description
It was reported that during a rotator cuff repair slil reconstruction surgery the implant broke while being screwed into a pre-drilled hole, causing the suture breakage.The broken pieces remains inside the patient.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
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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 is attributed to misuse due to prying/leveraging the device during use.
Additional Manufacturer Narrative
Correction: d2a, d2b.

• 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: 19589055
• Report Number: 1220246-2024-06341
• Device Sequence Number: 3340248
• Product Code: MBI
• UDI-Device Identifier: 00888867022614
• UDI-Public: 00888867022614
• 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,Followup,Followup
• Report Date (Section B): 07/29/2025

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: 15157689
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2024
• Supplement Date Received by Manufacturer: Not provided; 06/05/2025; Not provided
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 07/23/2024; 06/25/2025; 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2023
• 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