MAUDE Adverse Event Report: ARTHREX, INC. T10 HEXALOBE SHAFT, SOLID, STRAIGHT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	T10 HEXALOBE SHAFT, SOLID, STRAIGHT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 07/19/2023, it was reported by a sales representative via sems that an ar-8950sd-10 t10 hexalobe shaft had an issue.During an unknown procedure, when trying to remove a 3.5 headless compression ft screw, part of the tip broke off in the screw.They were able to use a dental pick and get the piece out and used another driver handle.Part of the screw ended up breaking as well but left half of the screw in.This occurred during use with no patient harm.Additional information has been requested.On 8/1/2023, the sales representative stated the following additional information over the phone: this occurred during a revision surgery.The initial midfoot fusion surgery with unknown arthrex parts took place within the last year and was successful, but the patient afterward still experienced pain.During the revision surgery, the surgeon removed a compression dynanite plate and tried to remove two ar-8730-32h mini compression ft screws.When trying to remove the first screw, the tip of the hexalobe shaft broke off in the screw, but they were able to remove that fragment from the screw by using a dental pick.When a driver handle was used to remove that first screw afterward, about 1 inch of the screw broke off and was removed, and the other 2-inch part of that screw remained inside the patient and could not be extracted.The bone quality of the patient was very good.The second screw was then left untouched inside the patient.The revision surgery was still deemed successful, with the plate being removed, and a third new ar-8730-32h mini compression ft screw was affixed into the bunion.No case delay was reported, the revision surgery was deemed successful by the doctor, and the patient is fine to date.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: h6 complaint is confirmed.Upon visual inspection, it was noted that the drive geometry at the distal tip of the returned ar-8950sd-10 had both twisted and broken.No fragments were returned for inspection.Functional test was not performed due to the damage to the device.The most likely cause is attributed to over-torquing/over-engaging the driver within the screw head.

• Brand Name: T10 HEXALOBE SHAFT, SOLID, STRAIGHT
• 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: emily shafer ; 8009337001
• MDR Report Key: 17571409
• Report Number: 1220246-2023-07540
• Device Sequence Number: 8400225
• Product Code: LXH
• UDI-Device Identifier: 00888867220010
• UDI-Public: 00888867220010
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 10/27/2023

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: T10 HEXALOBE SHAFT, SOLID, STRAIGHT
• Device Catalogue Number: AR-8950SD-10
• Device Lot Number: 1392302
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown