MAUDE Adverse Event Report: ARTHREX, INC. QCKFIX SCRW,TI,CANC.,PT,3.0X 32MM; BONE FIXATION SCREW/PLATE

Model Number	QCKFIX SCRW,TI,CANC.,PT,3.0X 32MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a mtp surgery the screw head broke off when inserted.The broken head was retrieved out of the patient.The implanted part of the screw remained fixated in the patients bone.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully.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.The complaint allegation is confirmed.One unpackaged alleged ar-8730-32pt low profile screw¿, ti, 3.0 mm x 32 mm, cancellous, partially threaded, was received for investigation.Only the head of the screw was received for evaluation.The visual evaluation revealed that the head of the screw was detached from the screw body at the transition with the shaft.The received piece was evaluated under a magnifier, and damage was noted on the hex head geometry.The received screw piece's outside diameter was measured by drawing c3135 at revision 5.Outside diameter ø.162 +.000/-.006 results: ø.159.The most likely cause(s) for the reported failure can be attributed to user error, improper bone preparation, misaligned insertion, or excessive forces through leveraging/prying the device.

• Brand Name: QCKFIX SCRW,TI,CANC.,PT,3.0X 32MM
• 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: 20028947
• Report Number: 1220246-2024-07201
• Device Sequence Number: 18004225
• Product Code: HWC
• UDI-Device Identifier: 00888867045859
• UDI-Public: 00888867045859
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 01/03/2025

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 32MM
• Device Catalogue Number: AR-8730-32PT
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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