MAUDE Adverse Event Report: ARTHREX, INC. QUICKFIX SCREW, 3 X 13 MM, STERILE; BONE FIXATION SCREW/PLATE

Model Number	QUICKFIX SCREW, 3 X 13 MM, STERILE
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a weil osteotomy, the screw did not snap off when it was screwed in.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a different device (ar-8930-13s).It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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 for the reported failure can be attributed to misuse due to use error/mishandling.

• Brand Name: QUICKFIX SCREW, 3 X 13 MM, STERILE
• 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: 22159982
• Report Number: 1220246-2025-02403
• Device Sequence Number: 20674882
• Product Code: HWC
• UDI-Device Identifier: 00888867049314
• UDI-Public: (01)00888867049314(11)230613(17)280531(10)15103691
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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: QUICKFIX SCREW, 3 X 13 MM, STERILE
• Device Catalogue Number: AR-8931-13S
• Device Lot Number: 15103691
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2023
• 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