MAUDE Adverse Event Report: ARTHREX, INC. QUICKFIX SCREW, 2 X 14 MM, STERILE; BONE FIXATION SCREW/PLATE

Model Number	QUICKFIX SCREW, 2 X 14 MM, STERILE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery on the (b)(6) 2024 when using the device the screw broke.There was no harm for patient, operator or third party reported.No further information received.Update avoe 07-apr-2024.It was confirmed that the error occurred during a weil osteotomy on the (b)(6) 2024.The screw broke during insertion without pressure.According to the surgeon no harm for patient, operator or third party occurred.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 avoe 08-apr-2024 it was confirmed that all fragments were retrieved from the patient.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged ar-8930-14s, batch number 15128846 was received for evaluation.Visual evaluation identified that the screw broke at the head, detaching the shaft.It was observed that the screw's head was slightly bent, likely due to excessive force.-the reported failure is most likely due to user error, such as misalignment during insertion, or prying/levering the device while inserting it.

• Brand Name: QUICKFIX SCREW, 2 X 14 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: 19166949
• Report Number: 1220246-2024-02274
• Device Sequence Number: 7938082
• Product Code: HWC
• UDI-Device Identifier: 00888867049239
• UDI-Public: 00888867049239
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• 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): 08/29/2024

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 14 MM, STERILE
• Device Catalogue Number: AR-8930-14S
• Device Lot Number: 15128846
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2023
• 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