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

Model Number	SUTURE ANCHOR, MICRO CORKSCREW FT
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/07/2024
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 an ulnar collateral ligament repair surgery the suture tore after inserting into the phalanx.The surgeon reported that the suture loaded into the anchor was already weakened before the anchor insertion.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 (b)(6) 10-oct-2024: the two devices ar-1318ft-1 remained inside the patient.
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 for the reported failure can be attributed to misuse due to mishandling/user error of the device due to excessive forces being applied during insertion.

• Brand Name: SUTURE ANCHOR, MICRO CORKSCREW FT
• 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: 20461499
• Report Number: 1220246-2024-08154
• Device Sequence Number: 15628703
• Product Code: HWC
• UDI-Device Identifier: 00888867282322
• UDI-Public: (01)00888867282322(11)240409(17)290331(10)15232054
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K112237
• 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): 05/28/2025

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, MICRO CORKSCREW FT
• Device Catalogue Number: AR-1318FT-1
• Device Lot Number: 15232054
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2024
• 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