MAUDE Adverse Event Report: ARTHREX, INC. QCKFIX SCRW,TI,CANN ST,CANC.,4.0X 50MM; SCREW, FIXATION, BONE

Model Number	QCKFIX SCRW,TI,CANN ST,CANC.,4.0X 50MM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/08/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported on (b)(6) 2022 by a sales representative via email that an ar-8740-50pts screw broke while inserting.This was discovered during a case and broke inside the patient.
Additional Manufacturer Narrative
Complaint is confirmed.The complaint is confirmed based on the customer provided photo, which displays the damage of the broken screw.However, without the return of the device for physical evaluation, the most likely cause of this condition is excessive friction/force during use or insertion.The cause remains error use.No change in harm was identified.

• Brand Name: QCKFIX SCRW,TI,CANN ST,CANC.,4.0X 50MM
• Common Device Name: SCREW, FIXATION, BONE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 15484175
• Report Number: 1220246-2022-05526
• Device Sequence Number: 15487071
• Product Code: HWC
• UDI-Device Identifier: 00888867046498
• UDI-Public: 00888867046498
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/05/2023

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 50MM
• Device Catalogue Number: AR-8740-50PTS
• Device Lot Number: 125080
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Supplement Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown