MAUDE Adverse Event Report: ARTHREX, INC. DISPOSABLE SLOTTED-CANNULATED PASSER, LG; MANUAL INSTR, GENERAL SURGICAL

Model Number	DISPOSABLE SLOTTED-CANNULATED PASSER, LG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 08-dec-2025, a sales representative reported via sems (b)(4) that an ar-7841 medium fibertape cerclage passer was utilized around the proximal femur and broke while pressure was applied on the handle during a revision total hip arthroplasty.All parts were removed from the patient and confirmed on x-ray.A second ar-7842 passer, size large, was opened to complete the cerclage pass.That passer also broke.Again, an x-ray confirmed that all parts were removed.In order to complete the case, a first-generation cerclage passer was opened and utilized around the femur.The case was completed successfully.Roughly 5 minutes were added to the procedure, but no second surgery was necessary.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is not confirmed.Visual inspection noted that the shaft of the fibertape® cerclage quickpass¿ passer, large, was bent, and no broken parts were found on the device.Functional testing was not performed due to the damage to the device.The most likely cause is attributed to user error of the device due to excessive force and or prying/leveraging/bending the device during use.

• Brand Name: DISPOSABLE SLOTTED-CANNULATED PASSER, LG
• 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: 23907590
• Report Number: 1220246-2025-05871
• Device Sequence Number: 18664532
• Product Code: LXH
• UDI-Device Identifier: 00888867480575
• UDI-Public: (01)00888867480575(11)250623(17)300531(10)15454902
• 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
• Report Date (Section B): 04/01/2026

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: DISPOSABLE SLOTTED-CANNULATED PASSER, LG
• Device Catalogue Number: AR-7842
• Device Lot Number: 15454902
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown