MAUDE Adverse Event Report: ARTHREX, INC. QCKFIX SCRW,TI,CANC.,PT,3.0X 38MM, STRL; BONE FIXATION SCREW/PLATE

Model Number	QCKFIX SCRW,TI,CANC.,PT,3.0X 38MM, STRL
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
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 metatarsophalangeal (mtp) fusion it appeared that there was something stuck in the cannulation and a guidewire would not go through it.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.Update (b)(6) 02-jun-2025.Further information was received that clarifies the issue further: it was reported that either there was something stuck in the screw or the cannulation was compromised so the screw did not fit over the guidewire.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a manufacturing issue; however, due to the device not being returned and no photos of the reported failure being provided, we are unable to confirm the reported event.

• Brand Name: QCKFIX SCRW,TI,CANC.,PT,3.0X 38MM, STRL
• 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: 22124370
• Report Number: 1220246-2025-02339
• Device Sequence Number: 7273978
• Product Code: HWC
• UDI-Device Identifier: 00888867210790
• UDI-Public: (01)00888867210790(11)240229(17)290131(10)15213896
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K143614
• 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): 11/03/2025

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: QCKFIX SCRW,TI,CANC.,PT,3.0X 38MM, STRL
• Device Catalogue Number: AR-8730-38PTS
• Device Lot Number: 15213896
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/29/2024
• 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