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

Model Number	SP FIBERTAK RC, DBLOAD TAPE BL/W, BLK/W
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
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 rotator cuff surgery the anchor did not hold.There was no harm for patient, operator or third party.The surgery was finished successfully by inserting a swivelock.It was not necessary to switch the surgical technique or do a second surgery.Update 11-oct-2023 nroe: further information was provided and revealed that the fibertak bent while being inserted into the bone.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint is confirmed.One unpackaged ar-3632sp-1 batch/serial number (b)(6) was received for evaluation.Upon visual evaluation it was noted that the shaft's tip was bent.The thickness of the tip was measured by drawing c18275 at revision 14.The results the device is within tolerances by drawing specifications.No functional test was performed for a bent device.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.The most likely cause(s) for the reported failure is prying/leveraging the device against bone or another instrument.Per dfu-0333-1 at revision 0.Precautions.5.Insert the anchor with the same orientation as that of the prepared drilled bone hole to avoid damage to the anchor or inserter.Insert the anchor with the same orientation as that of the prepared drilled bone hole to avoid damage to the anchor or inserter.

• Brand Name: SP FIBERTAK RC, DBLOAD TAPE BL/W, BLK/W
• 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: 17958799
• Report Number: 1220246-2023-08242
• Device Sequence Number: 20591963
• Product Code: MBI
• UDI-Device Identifier: 00888867341890
• UDI-Public: 00888867341890
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200341
• 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): 11/13/2024

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: 01/31/2026
• Device Model Number: SP FIBERTAK RC, DBLOAD TAPE BL/W, BLK/W
• Device Catalogue Number: AR-3632SP-1
• Device Lot Number: 12759541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2021
• 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