MAUDE Adverse Event Report: ARTHREX, INC. QCKFIX SCRW,TI,CANN ST,CANC.,4.0X 60MM; BONE FIXATION SCREW/PLATE

Model Number	QCKFIX SCRW,TI,CANN ST,CANC.,4.0X 60MM
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/30/2023, it was reported by a sales representative via email that an ar-8740-60pts cannulated low profile screw had a shiny metal, like plastic of resin, at the tip of the screw.This was discovered before use during a procedure on (b)(6) 2023.Additional information received on 12/7/2023: this was discovered during an ankle fracture procedure, and it was completed using another ar-8740-60pts cannulated low profile screw.The screw never came in contact with the patient.The case was not delayed, and no additional anesthesia was administered.The patient suffered no negative effects on or after the procedure.
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
Based on the customer-provided photo, the complaint allegation is confirmed.One unpackaged ar-8740-60pts cannulated low profile screw was received for evaluation.Visual inspection of the device noted no problems with the device.The customer-provided photos were inspected and it was noted that there was a plastic-like material at the tip of the ar-8740-60pts cannulated low profile screw.The most likely cause for the reported failure can be attributed to a supplier manufacturing issue.Refer to investigation photos.

• Brand Name: QCKFIX SCRW,TI,CANN ST,CANC.,4.0X 60MM
• 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: emily shafer ; 8009337001
• MDR Report Key: 18400691
• Report Number: 1220246-2023-09660
• Device Sequence Number: 2699196
• Product Code: HWC
• UDI-Device Identifier: 00888867046542
• UDI-Public: 00888867046542
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• 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,Followup
• Report Date (Section B): 08/19/2024

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: QCKFIX SCRW,TI,CANN ST,CANC.,4.0X 60MM
• Device Catalogue Number: AR-8740-60PTS
• Device Lot Number: 15151656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2023
• 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