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

Model Number	QCKFIX SCRW, CANN ST,4.0X 50MM, STRL
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a osteochondral defect treatment with bio-compression screw and medial malleolus osteotomy the screw head snapped off when screwing into the medial malleolus.The surgeon left the screw in the patient and was not worried about complications.The broken off head of the screw was retrieved from the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.
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 is confirmed based on the customer provided photo, which displays the broken head of the screw.However, without return of the device for physical evaluation, the cause remains undetermined.No change in harm was identified.

• Brand Name: QCKFIX SCRW, CANN ST,4.0X 50MM, STRL
• 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: 13620695
• Report Number: 1220246-2022-04525
• Device Sequence Number: 2096416
• Product Code: HWC
• UDI-Device Identifier: 00888867211490
• UDI-Public: 00888867211490
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2022

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 Expiration Date: 04/30/2022
• Device Model Number: QCKFIX SCRW, CANN ST,4.0X 50MM, STRL
• Device Catalogue Number: AR-8740-50PTSS
• Device Lot Number: 10139213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2022
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 05/11/2022
• Date Device Manufactured: 05/22/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown