MAUDE Adverse Event Report: ARTHREX, INC. DRIVER SHAFT, T-15, MEDIUM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DRIVER SHAFT, T-15, MEDIUM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 07/18/2025, a facility representative reported via (b)(4) that an ar-9545-t15-02 t-15 medium driver shaft tip broke off in the screw head of a suture cup while attempting to remove it in a revision scenario.The broken piece was retrieved.The reverse total shoulder procedure was successfully completed, and no patient was harmed.Additional information was received on 28-jul-2025: the original revision purpose was due to the patient dislocating their prosthesis.There was no allegation that the revision was due to a malfunction of an arthrex product.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-9545-t15-02 batch 8001844 was received for evaluation.Visual inspection revealed that the tip was broken off and the hex was twisted.The received instrument's overall length was measured by drawing c10181 at revision 5, component c10181-02 at revision 5.Overall length specification: oal: "b" 5.50 ±.01 inches.Results: 5.45 inches.Functional testing was not performed due to the damage to the device.The most likely cause of the reported failure is a user error, such as applying excessive force and/or over-torquing.

• Brand Name: DRIVER SHAFT, T-15, MEDIUM
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 22738126
• Report Number: 1220246-2025-03312
• Device Sequence Number: 9240241
• Product Code: LXH
• UDI-Device Identifier: 00888867225190
• UDI-Public: (01)00888867225190(11)181108(10)8001844
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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): 10/06/2025

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: DRIVER SHAFT, T-15, MEDIUM
• Device Catalogue Number: AR-9545-T15-02
• Device Lot Number: 8001844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown