MAUDE Adverse Event Report: ARTHREX, INC. QCKFIX SCRW,TI,CANN.,PT,2.0X 28MM; SCREW, FIXATION, BONE

Model Number	QCKFIX SCRW,TI,CANN.,PT,2.0X 28MM
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/23/2021
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 that during a metal removal surgery at the foot the head of each of the two devices broke already during the first turn of the screwdriver.The heads of the two devices were retrieved from the patient, but the rest of the device remained inside the patient.Therefore the ex-plantation of the devices wasn`t finished successfully.According to the surgeon no harm for patient, operator or third party occurred.Update avoe 29-apr-2021: it was confirmed that the surgery was finished successfully.The indentations, where the heads of the screws were embedded, were smoothed and a homogeneous surface was created.The patient was only bothered by the heads of the screws and therefore this incident is no harm for the patient.The devices were implanted on the (b)(6) 2018.
Additional Manufacturer Narrative
Complaint confirmed, two screw head fragments were returned.The fragments were not identified and could not be measured.The cause of the event is undetermined, however likely causes include prying/levering the device.

• Brand Name: QCKFIX SCRW,TI,CANN.,PT,2.0X 28MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11842483
• Report Number: 1220246-2021-03112
• Device Sequence Number: 11720217
• Product Code: HWC
• UDI-Device Identifier: 00888867045033
• UDI-Public: 00888867045033
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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.,PT,2.0X 28MM
• Device Catalogue Number: AR-8720-28PT
• Device Lot Number: 95241706
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/23/2021
• Patient Sequence Number: 1