MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK SUTURE ANCHOR; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERTAK SUTURE ANCHOR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
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 arthroscopic glenoid surgery the guidewire of the device fractured during implant insertion.According to the surgeon no harm for patient, operator or third party occurred.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 avoe 20-aug-2024: it was confirmed that the driver/inserter of the device broke and all fragments were retrieved.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-3600-1 fibertak¿ suture anchor 1.6 mm with #2 fiberwire® cl was received for investigation.Visual evaluation of the returned device noted no problems with the device.The driver/inserter was visually inspected under a magnifier and was not observed to be broken.Functional testing is not applicable to the reported failure.No problem found.Refer to investigation photos.Complaint allegation is not confirmed.

• Brand Name: FIBERTAK SUTURE ANCHOR
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 20140778
• Report Number: 1220246-2024-07366
• Device Sequence Number: 20682204
• Product Code: MBI
• UDI-Device Identifier: 00888867284814
• UDI-Public: 00888867284814
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K151230
• 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): 12/11/2024

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: FIBERTAK SUTURE ANCHOR
• Device Catalogue Number: AR-3600-1
• Device Lot Number: 15252995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2024
• 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