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	11/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint is confirmed.Device was received: ar-3632sp batch 12880859, unpackaged.Observation revealed that the shaft was bent near the distal tip.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces upon insertion.
Event or Problem Description
On 11/15/2021, it was reported by a sales representative via email that an ar-3632sp self-punching fibertak bent to one side, near the flat top of the inserter.Surgeon removed anchor, straightened the inserter, and with a mallet reattempted insertion of the anchor but it bent again.Concerned that the metal fibertak inserter may break inside he patient's shoulder, surgeon removed the anchor and used a new fibertak to complete the case successfully.Patient was not affected.

• 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: 18411030
• Report Number: 1220246-2023-09718
• Device Sequence Number: 2761077
• Product Code: MBI
• UDI-Device Identifier: 00888867341883
• UDI-Public: 00888867341883
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K200341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/28/2023

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
• Device Lot Number: 12880859
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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