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

Model Number	FIBERTAK WITH SUTURETAPE
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/07/2025
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 during the superior labral anterior posterior surgery that the anchor dislocated from the bone.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
Additional information: d9, g3, h3, h6.The complaint allegation regarding anchor dislocation during a superior labral anterior posterior (slap) surgery could not be confirmed.Due to device contamination, only a visual evaluation was performed.Photographic evidence provided for device ar-3602-1, batch number 15394338, showed torn sutures; however, no images were submitted that demonstrated anchor dislocation.Based on the available information¿which may include the returned device (if applicable), photographs, videos, event descriptions, and any additional field data¿arthrex determined the most probable cause of the reported failure.The most likely root cause may be attributed to misaligned insertion and/or prying or leveraging of the device during insertion.

• Brand Name: FIBERTAK WITH SUTURETAPE
• 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: 22663269
• Report Number: 1220246-2025-03130
• Device Sequence Number: 19789548
• Product Code: MBI
• UDI-Device Identifier: 00888867287099
• UDI-Public: (01)00888867287099(11)250224(17)300131(10)15394338
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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: FIBERTAK WITH SUTURETAPE
• Device Catalogue Number: AR-3602-1
• Device Lot Number: 15394338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown