MAUDE Adverse Event Report: ARTHREX, INC. SP FBRTAK RC FBRTPE BLU & STTPE WH/BLK; NON-DEGRADABLE FIXATN FASTENER

Model Number	SP FBRTAK RC FBRTPE BLU & STTPE WH/BLK
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a medial patellofemoral ligament (mpfl) surgery using the devices ar-1324hf (lot: 13660505) and ar-3652tsp-1 (lot: 15117287 & 15054185) the implants did not hold in bone tissue and tore out.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.
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 is confirmed.Upon visual evaluation, it was noted that the implant and blue suture of the fibertak® rc suture anchor, (blue) had torn out.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force used during suture passing/tightening /tensioning.

• Brand Name: SP FBRTAK RC FBRTPE BLU & STTPE WH/BLK
• 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: 18047774
• Report Number: 1220246-2023-08494
• Device Sequence Number: 7465134
• Product Code: MBI
• UDI-Device Identifier: 00888867362932
• UDI-Public: 00888867362932
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203268
• 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): 07/29/2024

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 Model Number: SP FBRTAK RC FBRTPE BLU & STTPE WH/BLK
• Device Catalogue Number: AR-3652TSP-1
• Device Lot Number: 15054185
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2023
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 07/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown