MAUDE Adverse Event Report: T. A. G. MEDICAL PRODUCTS CORP., LTD. FIBERSTITCH; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	AR-4570-24
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Patient presented to operating room for right knee arthroscopy repair of medial meniscus.During the procedure a 25mm piece of arthrex fiberstitch broke off into patient.The broken piece was retrieved intact.Fda safety report id# (b)(4).

• Brand Name: FIBERSTITCH
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): T. A. G. MEDICAL PRODUCTS CORP., LTD.; kibbutz gaaton 25130 00; IS 2513000
• MDR Report Key: 15626112
• Report Number: MW5112693
• Device Sequence Number: 14921046
• Product Code: MBI
• UDI-Device Identifier: 10818674025703
• UDI-Public: (01)10818674025703
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/14/2022

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: 22E10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White