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

Model Number	FIBERTAK WITH SUTURETAPE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopy glenoid reconstruction surgery after inserting the anchor into the prepared channel, the end of the guidewire fractured inside the patient.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) 2023 nroe: the broken pieces were retrieved from patient.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: d9, g3, h6.The complaint is confirmed.One unpackaged ar-3602-2 serial/batch number (b)(6) was received for investigation.Visual evaluation found that the shaft tip was broken off.No functional test was performed due to the damaged tip.Measurement of the shaft length by drawing c10441 at revision 16 (length.9.90 ±.02) gives a result of 9.12, indicating a failure; the shaft is shorter due to the broken piece.Additionally, the tip thickness was measured per drawing c14519 at revision 1.(.024 ±.002), resulting in a pass that indicated the device tip thickness was into tolerances.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.A user error is the most likely cause(s) for the reported and observed failure, hitting the device with another device or object, prying/leveraging, or excessive bending forces applied during use.

• 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: emily shafer ; 8009337001
• MDR Report Key: 17782872
• Report Number: 1220246-2023-07962
• Device Sequence Number: 15172660
• Product Code: MBI
• UDI-Device Identifier: 00888867287099
• UDI-Public: 00888867287099
• 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): 03/05/2024

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 Expiration Date: 07/31/2025
• Device Model Number: FIBERTAK WITH SUTURETAPE
• Device Catalogue Number: AR-3602-1
• Device Lot Number: 11568140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2020
• 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