MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, CORKSCREW FT II; BONE FIXATION SCREW/PLATE

Model Number	SUTURE ANCHOR, CORKSCREW FT II
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
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 the corksrew anchorage loosened 6 weeks after surgery and a revision surgery was performed to correct this.No further information was received.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Update avoe (b)(6) 2024.Further information was provided that during the initial surgery a removal of a haglund's exostosis and an open reinsertion of the achilles tendon in a degenerative rupture was performed using the reported devices ar-1928sf-2 (lot: 14743165).6 weeks postoperatively without further trauma a material failure of the devices occurred, so that a new operation was necessary.Intraoperatively, the sutures all appeared to be no longer connected to the titanium anchors, although these had not been torn out in the area of the tendon.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Visual evaluation of the two ar-1928sf-2s note that one has a slight bend to the distal tip.The second ar-1928sf-2 has no damage.Functional testing could not be performed due to contamination on the devices.The most likely cause for the reported failure can be attributed to a patient-specific event.See referenced photos attached.Complaint allegation is confirmed.

• Brand Name: SUTURE ANCHOR, CORKSCREW FT II
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: 20418983
• Report Number: 1220246-2024-08089
• Device Sequence Number: 12872892
• Product Code: HWC
• UDI-Device Identifier: 00888867023703
• UDI-Public: (01)00888867023703(11)211215(17)261130(10)14743165
• 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,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SUTURE ANCHOR, CORKSCREW FT II
• Device Catalogue Number: AR-1928SF-2
• Device Lot Number: 14743165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 10/23/2024; 03/19/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 11/05/2024; 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown