MAUDE Adverse Event Report: Arthrex, Inc. QUICKFIX SCREW, 2 X 12 MM; BONE FIXATION PLATE

Model Number	QUICKFIX SCREW, 2 X 12 MM
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-8930-12 quickfix¿, batch 15548952 was received for investigation.Visual evaluation observed that the device was bent at the snap-off location.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user-related procedural factors encountered during device insertion and removal.Crew is designed to separate following complete seating of the implant and deliberate bending of the shaft in a single direction rather than from insertion torque alone.If the implant is not fully seated, the snap feature is not flush, or the separation technique differs from the recommended bending method, separation may not occur as expected.The application of increased force following insertion resistance likely contributed to deformation of the screw and advancement through the cortical bone.The complaint allegation is confirmed.Refer to the investigation photos.

• Brand Name: QUICKFIX SCREW, 2 X 12 MM
• Common Device Name: BONE FIXATION PLATE
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50101548
• Report Number: 1220246-2026-04149
• Device Sequence Number: 18650158
• Product Code: HRS
• UDI-Device Identifier: 00888867049185
• UDI-Public: (01)00888867049185(11)251222(10)15548952
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K052614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/31/2026

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, 2 X 12 MM
• Device Catalogue Number: AR-8930-12
• Device Lot Number: 15548952
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/22/2025
• 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