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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via (b)(4) that an ar-8750-03 driver shaft, t15 hexalobe, cannulated had the tip of the screw break off in the head of the screw when the surgeon was trying to back out the screw.The case was completed successfully, with no pieces breaking off inside the patient.This was discovered during a hardware removal procedure on (b)(6) 2024, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-8750-03, driver shaft, t15 hexalobe, batch 1392327, was received for investigation.Upon visual evaluation, noted that the distal tip of the inserter shaft was broken.No broken pieces were returned for investigation.Functional testing could not be performed due to the damage of the device.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device, as the driver should not be used for removal of the screw.
Event or Problem Description
Additional information was received on 11/04/2024: there was no case delay.The hardware removal procedure was for the removal of the arthrex part ar-8750-50h 5.0 large compression ft screw, which was explanted during the surgery.At this time, it is unknown why the patient underwent revision surgery.No arthrex products were implanted during this surgery.

• 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: jared engle ; 8009337001
• MDR Report Key: 20599334
• Report Number: 1220246-2024-08382
• Device Sequence Number: 6528323
• Product Code: LXH
• UDI-Device Identifier: 00888867263765
• UDI-Public: (01)00888867263765(11)230720(10)1392327
• 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
• Report Date (Section B): 12/04/2024

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: 1392327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown