MAUDE Adverse Event Report: ARTHREX, INC. ELEVATOR, 30 DEGREE SHOULDER TISSUE; MANUAL INSTR, GENERAL SURGICAL

Model Number	ELEVATOR, 30 DEGREE SHOULDER TISSUE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a bankart surgery the tip of the device broke off.No part of the device remained inside the patient.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
The reported event was confirmed as one unpackaged ar-1342-30, elevator, 30 degree shoulder tissue, batch number 052413, was received for investigation and upon visual inspection, it was observed that the tip is broken off (see evaluation picture 3).Functional testing was not performed due to the damage of the device.No fragments were returned for evaluation.The most likely cause of the reported failure can be attributed to the application of excessive levering forces.Further, the device shows signs of metal surface oxidation (see evaluation pictures 3 + 4).

• Brand Name: ELEVATOR, 30 DEGREE SHOULDER TISSUE
• 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: 24831442
• Report Number: 1220246-2026-02100
• Device Sequence Number: 13369653
• Product Code: MDM
• UDI-Device Identifier: 00888867012684
• UDI-Public: (01)00888867012684(11)240730(10)052413
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 04/09/2026

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: ELEVATOR, 30 DEGREE SHOULDER TISSUE
• Device Catalogue Number: AR-1342-30
• Device Lot Number: 052413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2024
• 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