MAUDE Adverse Event Report: ARTHREX, INC. BRIDGE, XL,QC, 2 STPCK F/3.5MM HIP SCOPE; ARTHROSCOPIC ACCESSORIES

Model Number	BRIDGE, XL,QC, 2 STPCK F/3.5MM HIP SCOPE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the hip arthroscopy, a stopcock of the device broke off.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a different device (ar-3373-4002h).It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: BRIDGE, XL,QC, 2 STPCK F/3.5MM HIP SCOPE
• Common Device Name: ARTHROSCOPIC ACCESSORIES
• 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: 25028355
• Report Number: 1220246-2026-02550
• Device Sequence Number: 10126914
• Product Code: NBH
• UDI-Device Identifier: 00888867195448
• UDI-Public: (01)00888867195448(11)230605(10)1742751
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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: BRIDGE, XL,QC, 2 STPCK F/3.5MM HIP SCOPE
• Device Catalogue Number: AR-3380-4004H
• Device Lot Number: 1742751
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2023
• 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