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

Model Number	SCREWDRIVER, T15 HEXALOBE
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/15/2024, it was reported by a distributor via (b)(4) that an ar-8943-10 screwdriver's black and yellow stripes were peeling.This occurred during a reverse total shoulder arthroplasty on (b)(6) 2024 when it was noticed the peeling and the driver was considered unacceptable to use for surgery according to the sterile processing department.Another screwdriver was available and used for the surgery.No adverse events to the patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 10/21/2024 additional information was received from an arthrex employee who stated the surgery took place on (b)(6) 2024, but the wear and tear on the instrument just occurred over time.No attachment or adapter with this screwdriver.No debris was found, but probably fell off in the washers in spd.Instrument ar-9545-t15-01 in the tray was used to complete the surgery.A photo of the screwdriver is attached with the peeled black and yellow stripes.
Additional Manufacturer Narrative
Additional information: b5, g3.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The failed device was not received for evaluation.Based on the provided information, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional details from the field, arthrex concluded the most likely cause of the reported failure.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.Instrument manufacturing date: 2021.The complaint allegation was confirmed based on the customer's attached picture, which shows the instrument with signs of wear.

• Brand Name: SCREWDRIVER, T15 HEXALOBE
• 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: 20577859
• Report Number: 1220246-2024-08352
• Device Sequence Number: 8170995
• Product Code: LXH
• UDI-Device Identifier: 00888867052208
• UDI-Public: 00888867052208
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/19/2025

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: SCREWDRIVER, T15 HEXALOBE
• Device Catalogue Number: AR-8943-10
• Device Lot Number: 1392116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 10/21/2024; 08/18/2025
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 12/19/2024; 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown