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 Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during a shoulder arthroscopy the implant and the suture broke.There was no harm for patient, operator or third party reported.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
Complaint is not confirmed.Upon visual evaluation, the returned suture assembly only has a piece of the fiber tape white/black.The anchor or white/blue suture was not returned for investigation.The distal end of the shaft was bent.The most likely cause of this condition is the excessive force used to pry and/or leverage 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: 16361779
• Report Number: 1220246-2023-06275
• Device Sequence Number: 20680381
• 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): 08/03/2023

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: SP FIBERTAK RC, DBLOAD TAPE BL/W, BLK/W
• Device Catalogue Number: AR-3632SP-1
• Device Lot Number: 15005234
• 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: 01/27/2023
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown