MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK DISPOSABLES CURVED KIT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	FIBERTAK DISPOSABLES CURVED KIT
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 22nd may 2025, it was reported by an arthrex employee via email that for an ar-3638dc, knotless fibertak¿ disposable kit, curved, when the surgeon used drill guide and drill bit from ar-3638dc to repair capsule during latarjet procedure, he encountered some resistance but eventually was able to implant the anchor and convert the knotless mechanism.This was detected during a latarjet procedure on (b)(6) 2025.Procedure was completed successfully as normal.On (b)(6) 2025 - the complaint initiator replied that the broken drill bit is identified in white.Drill bit is yet to be retrieved but will be soon.Patient will need to be revised to remove the drill bit.On (b)(6) 2025 - the complaint initiator replied that the broken piece was retrieved from the patient and it was determined to be ar-3636 lot number 15371028.This was determined only during the procedure to remove the broken part.It was further clarified that ar-3636 lot number 15371028 was also used in the original laterjet procedure and it turned out that it was the device that broke as it was only determined upon revision procedure and removal.
Additional Manufacturer Narrative
Investigation is in process.Follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on the customer-provided picture.Visual evaluation of the customer provided imaging noted a metal fragment remained in the patient.Refer to attachments.Based on the information provided which may include pictures, the 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 applying excessive mechanical forces upon insertion, improper bone prep and/or prying/leveraging the device during use.

• Brand Name: FIBERTAK DISPOSABLES CURVED KIT
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 22224901
• Report Number: 1220246-2025-02468
• Device Sequence Number: 20975161
• Product Code: LXH
• UDI-Device Identifier: 00888867287433
• UDI-Public: (01)00888867287433(11)250127(17)291231(10)15379073
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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: FIBERTAK DISPOSABLES CURVED KIT
• Device Catalogue Number: AR-3638DC
• Device Lot Number: 15379073
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2025
• 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