MAUDE Adverse Event Report: ARTHREX, INC. SP FIBERTAK RC, DBLOAD TAPE BL/W, BLK/W; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	SP FIBERTAK RC, DBLOAD TAPE BL/W, BLK/W
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder arthroscopy there was no blockage in the bone with the device.No part of the device broke off.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or do a second surgery.Update 15-mar-2022: it was confirmed that after inserting the fibertak self-punching anchor and removing the anchor guide, the surgeon, in order to check whether the anchor is sitting ¿anchored¿, pulled the straps as always and unfortunately the anchor fell out of the bone.A second device was used in the same place and this time the anchor has "anchored".
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
Complaint confirmed.Visual evaluation showed damage/fray to one of the ends of the soft anchor sheath.No damaged was observed to the suture construct or inserter shaft.Critical dimension for the length of the soft anchor sheath was not performed due to the damage/fray to one of the ends.Device testing was not performed due to the damage of the device.The cause of this event is undetermined; however, the most likely causes are improper bone prep, misaligned insertion, prying and/or leveraging the device.

• Brand Name: SP FIBERTAK RC, DBLOAD TAPE BL/W, BLK/W
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 13994806
• Report Number: 1220246-2022-04681
• Device Sequence Number: 20161115
• Product Code: MBI
• UDI-Device Identifier: 00888867341890
• UDI-Public: 00888867341890
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K200341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2022

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: 08/31/2026
• Device Model Number: SP FIBERTAK RC, DBLOAD TAPE BL/W, BLK/W
• Device Catalogue Number: AR-3632SP-1
• Device Lot Number: 14146868
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown