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

Model Number	SCREWDRIVER, T15 HEXALOBE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Foreign Body In Patient (2687)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 6/3/2024, it was reported by a patient via email that an ar-8943-10 t15 hexalobe screwdriver broke during a procedure and was left in the patient.The patient is experiencing a potential allergic reaction and has requested the material composition of the screwdriver.No additional information has been reported.Additional information received on 6/4/2024: the patient reported that on (b)(6) 2024, the patient underwent acl, let, medial meniscectomy, and lateral meniscal repair procedure.During the procedure, the surgeon used the screwdriver in an attempt to remove hardware from a posterolateral corner surgery performed on (b)(6) 2011.The attempt failed when the tip of the screwdriver broke in the screw.Twelve other instruments were then used in the removal efforts, but were unsuccessful.Alterations were made to the surgical plan, and the surgeon proceeded to leave the tip of the screwdriver in with the stuck screw.No other complications were noted during the surgery.The patient is experiencing skin reaction to the surgical dressing, continued increase in overall skin sensitivity, new onset circulation issues, difficulty staying warm even in warm environments, numbness of hands and feet, white hands and feet, oral thrush, abdominal pain, diarrhea, and vomiting.On (b)(6) 2024, the patient was treated with nystatin for the oral thrush.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint allegation is confirmed.Based on the images provided from the field it is evident that the patient was having adverse reactions throughout her body.The most likely cause of the reported failure is a patient-specific event.

• 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: 19656126
• Report Number: 1220246-2024-06548
• Device Sequence Number: 20538783
• Product Code: LXH
• UDI-Device Identifier: 00888867052208
• UDI-Public: 00888867052208
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SCREWDRIVER, T15 HEXALOBE
• Device Catalogue Number: AR-8943-10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 34 YR
• Patient Sex: Female