MAUDE Adverse Event Report: ARTHREX, INC. T15 HEXALOBE, ISO, CANN.; ORTHOPEDIC MANUAL SURG INSTR

Model Number	T15 HEXALOBE, ISO, CANN.
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 07/17/2023, it was reported by a sales representative via sems that (2) ar-8750-03 driver shafts, and (2) ar-8750-06 driver shafts failed to remove screws.This occurred during a case on (b)(6) 2023, the proper technique was used however the surgeon was unable to successfully remove the screws with the proper equipment.There was no additional information provided, additional information has been requested.Additional information was provided on 08/01/2023, it was reported that the drivers are twisted on most and the tip broke off of one completely, the representative was unsure of which device broke.Additional information was provided on 08/16/2023, the drivers from the set were used in an attempt to remove the screws, but they were unsuccessful.They had to use a synthes screw removal set with several other drivers and larger, deeper, trephines to get the screws out.One of the 2 screws broke and only a portion of the screw was retrieved.They believe the screw was 40mm long and they removed about 15-20mm of the broken screw.They left the rest in as they didn¿t feel it was safe or responsible to try to get the rest of it out.Additional information has been requested.
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: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause is attributed to misuse due to use error of over-torquing/over-engaging the driver with the screw head.

• Brand Name: T15 HEXALOBE, ISO, CANN.
• 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: 17644658
• Report Number: 1220246-2023-07660
• Device Sequence Number: 5590916
• Product Code: LXH
• UDI-Device Identifier: 00888867263765
• UDI-Public: 00888867263765
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/30/2024

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: T15 HEXALOBE, ISO, CANN.
• Device Catalogue Number: AR-8750-03
• Device Lot Number: 011923
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2019
• 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