MAUDE Adverse Event Report: ARTHREX, INC. QCKFIX SCRW,TI,CANN.,PT,2.4X 16MM; SCREW, FIXATION, BONE

Model Number	QCKFIX SCRW,TI,CANN.,PT,2.4X 16MM
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/14/2020
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that during a chevron bunion procedure the surgeon was implanting the ar-8724-16pt, quickfix screw, when the anchor broke.The distal end of the screw was unable to be retrieved and remains in the patient.For the implantation of the screw they placed the guidewire, used the countersink to prep the cortical bone, measured the screw, then placed the screw.The screw is self drilling/ self tapping so it was not necessary to drill the bone.The proximal portion of the anchor is being returned for evaluation.To complete the case the surgeon had to reposition the guidewire and go at a different trajectory with a different screw.
Additional Manufacturer Narrative
Complaint confirmed, the screw broke.The fragment returned measured about 12 mm long.Measurable features indicate the device met specifications.The cause is undetermined, however likely causes of such an event include prying/leveraging the device during insertion.

• Brand Name: QCKFIX SCRW,TI,CANN.,PT,2.4X 16MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10482065
• Report Number: 1220246-2020-02107
• Device Sequence Number: 16448609
• Product Code: HWC
• UDI-Device Identifier: 00888867045149
• UDI-Public: 00888867045149
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: QCKFIX SCRW,TI,CANN.,PT,2.4X 16MM
• Device Catalogue Number: AR-8724-16PT
• Device Lot Number: 95241226
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other