MAUDE Adverse Event Report: T.A.G. MEDICAL PRODUCTS CORPORATION LTD FIBERSTITCH¿ IMPLANT, 24° CURVE WITH TWO POLYESTER IMPLANTS AND 2-0 FIBERWIRE® S; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	AR-4570-24
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Pt came in for right knee arthroscopy acl repair.In the middle of surgery, fiberstitch tip broke off inside pt.And md retrieved the broken piece and case continued.Pt discharged to pacu in stable condition.Entire fiberstitch unit retrieved and given to nurse manager.

• Brand Name: FIBERSTITCH¿ IMPLANT, 24° CURVE WITH TWO POLYESTER IMPLANTS AND 2-0 FIBERWIRE® S
• 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: 19679744
• Report Number: 19679744
• Device Sequence Number: 6851895
• Product Code: MBI
• UDI-Device Identifier: 10818674025703
• UDI-Public: (01)10818674025703
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/21/2024
• Report Date (Section F): 02/21/2024

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: AR-4570-24
• Device Catalogue Number: 174000AR
• Device Lot Number: 21N09
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/05/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/05/2024
• 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
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Hispanic
• Date Report Sent to FDA: 02/21/2024