MAUDE Adverse Event Report: T.A.G. MEDICAL PRODUCTS CORPORATION LTD FIBERSTITCH IMPLANT, CURVED WITH TWO POLYESTER IMPLANTS AND 2-0 FIBERWIRE® SUTU; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	AR-4570
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the surgical procedure, there was 1 area in the posterior aspect where this anchor failed and per the surgical report, "led to some additional meniscus tearing in this region." the metal tip of this anthrex fiberstitch device broke completely and had to be retrieved from inside the patient's knee.The needle tip was easily visualized and removed without incident.The report states, "out of an abundance of caution at the end of the case x-rays were performed.No metallic foreign body was identified.".

• Brand Name: FIBERSTITCH IMPLANT, CURVED WITH TWO POLYESTER IMPLANTS AND 2-0 FIBERWIRE® SUTU
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): T.A.G. MEDICAL PRODUCTS CORPORATION LTD; 13252 woodland park rd; herndon VA 20171
• MDR Report Key: 18181475
• Report Number: 18181475
• Device Sequence Number: 7626049
• Product Code: MBI
• UDI-Device Identifier: 10818674021798
• UDI-Public: (01)10818674021798
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2023
• Report Date (Section F): 11/13/2023

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: AR-4570
• Device Catalogue Number: 171000AR
• Device Lot Number: 22K101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/21/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Race: White
• Date Report Sent to FDA: 11/13/2023