MAUDE Adverse Event Report: ARTHREX, INC. FIBERWIRE GRASPER W/ SR HANDLE; MANUAL INSTR, GENERAL SURGICAL

Model Number	FIBERWIRE GRASPER W/ SR HANDLE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/30/2024, it was reported by a sales representative via (b)(4) that an ar-13975sr fiberwire® grasper broke.This occurred during a shoulder arthroscopy on (b)(6) 2024.The bottom jaw broke off while inserting the instrument into the joint.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
On (b)(6) 2024 additional information was received by a sales representative via email who stated that the procedure performed was a shoulder scope.The device while inserting into a cannula.No arthrex rep was present.Patient's bone quality was unknown.All fragments were retrieved from the patient.A kingfisher was used to complete the procedure.There were no delays or need for additional anesthesia.
Event or Problem Description
On (b)(6) 2024 additional information was received by a sales representative via email who stated that the procedure performed was a shoulder scope.The device while inserting into a cannula.No arthrex rep was present.Patient's bone quality was unknown.All fragments were retrieved from the patient.A kingfisher was used to complete the procedure.There were no delays or need for additional anesthesia.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 complaint allegation is confirmed.Visual inspection noted that the bottom jaw was broken off.Functional testing was not performed due to the broken jaw of the fiberwire® grasper w/sr handle.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage in the field.

• Brand Name: FIBERWIRE GRASPER W/ SR HANDLE
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: jared engle ; 8009337001
• MDR Report Key: 20758995
• Report Number: 1220246-2024-08592
• Device Sequence Number: 18457567
• Product Code: NBH
• UDI-Device Identifier: 00888867015838
• UDI-Public: (01)00888867015838(10)69081
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup,Followup
• Report Date (Section B): 02/03/2025

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: FIBERWIRE GRASPER W/ SR HANDLE
• Device Catalogue Number: AR-13975SR
• Device Lot Number: 69081
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 11/04/2024; 01/07/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 12/20/2024; 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown