MAUDE Adverse Event Report: ARTHREX, INC. TENODESIS SCREW, PEEK; BONE FIXATION SCREW/PLATE

Model Number	TENODESIS SCREW, PEEK
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a tendon fixation in the hand the screw did not come off the screwdriver.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is confirmed.One unpackaged ar-1530ps, eek-tenodesis¿ screw with handled inserter 3 mm x 8 mm, batch number 15233489, was received for investigation.Visual evaluation noted that the threads of the peek of the device were broken/damaged.Functional testing wasn't performed due to the damage to the device.The most likely cause of the reported failure is user error in the device, which can be attributed to prying/leveraging, over-torquing/over-engaging the device during use.

• Brand Name: TENODESIS SCREW, PEEK
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: 21867249
• Report Number: 1220246-2025-01586
• Device Sequence Number: 7917055
• Product Code: HWC
• UDI-Device Identifier: 00888867018662
• UDI-Public: (01)00888867018662(11)240411(17)290331(10)15233489
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

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: TENODESIS SCREW, PEEK
• Device Catalogue Number: AR-1530PS
• Device Lot Number: 15233489
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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