MAUDE Adverse Event Report: ARTHREX, INC. DRIVER SHAFT, T4, NON-RETAINING, MINI AO; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DRIVER SHAFT, T4, NON-RETAINING, MINI AO
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
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 05/06/2025, a sales representative reported via email that the tip of the ar-18700-29 driver shaft broke off in the head of the ar-18714v-06 val screw as the surgeon was advancing it into the ar-18714p-21 hook plate.The broken pieces were retrieved from the patient.The ar-18700-29 driver shaft was being used with the jeweler's knob handle ar-18700h.The surgeon wanted to replace the screw, but the only way to remove it was to cut the tines off the ar-18714p-21 hook plate, remove each tine from the patient, and rotate the plate counterclockwise to back out the locking screw.The case was completed, and no further details were provided.This was discovered during an orif middle phalanx fracture procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested on 05/27/2025.
Event or Problem Description
Additional information was received on (b)(6) 2025: the broken shaft tip of the ar-18700-29 driver shaft was found inside the head of the ar-18714v-06 val screw that was removed.It remains uncertain whether the screw head became stripped due to the issue, as the driver tip was lodged inside.The tines of the ar-18714p-21 hook plate were successfully cut without complications, and no unplanned incisions resulted from the incident.No x-rays or photos were taken to document the event.There was no reported case delay, and no additional anesthesia was required.The patient's health status is stable, with no adverse effects observed during or after surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-18700-29 driver shaft fragment was received for investigation within an ar-18714v-06 val screw.Visual evaluation of the returned fragment noted it was stuck within the head of an ar-18714v-06 val screw.Functional testing was not able to be performed due to the damage to the device.The most likely cause for the reported failure can be attributed to overstressing a device that is damaged naturally and inevitably as a result of normal wear or aging from repeated usage/reprocessing.Manufactured date: 08-oct-2019.

• Brand Name: DRIVER SHAFT, T4, NON-RETAINING, MINI AO
• 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: 22097928
• Report Number: 1220246-2025-02262
• Device Sequence Number: 7343193
• Product Code: LXH
• UDI-Device Identifier: 00888867303553
• UDI-Public: (01)00888867303553(11)191008(10)1391940
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/07/2025

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, T4, NON-RETAINING, MINI AO
• Device Catalogue Number: AR-18700-29
• Device Lot Number: 1391940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 05/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: Not provided; 09/30/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/23/2025; 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown