MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK WITH #2 TIGERTAIL DOUBLE LOADED; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERTAK WITH #2 TIGERTAIL DOUBLE LOADED
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a biceps tendon fixation surgery the anchor pulled out.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
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-3603-2 serial/batch number (b)(6) was received for investigation.The visual evaluation revealed that the device arrived for evaluation without the anchor.During the evaluation of the inserter shaft, a warp was noted at the distal end.Functional testing does not apply for this device that arrives damaged for evaluation.The most likely cause can be attributed to improper bone preparation or prying/leveraging the device during insertion.

• Brand Name: FIBERTAK WITH #2 TIGERTAIL DOUBLE LOADED
• 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: 20084671
• Report Number: 1220246-2024-07281
• Device Sequence Number: 12703843
• Product Code: MBI
• UDI-Device Identifier: 00888867231320
• UDI-Public: 00888867231320
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K181769
• 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): 12/27/2024

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 WITH #2 TIGERTAIL DOUBLE LOADED
• Device Catalogue Number: AR-3603-2
• Device Lot Number: 15174824
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2023
• 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