MAUDE Adverse Event Report: ARTHREX, INC. QCKFIX SCRW,TI,CANN ST,CANC.,4.0X 46MM; SCREW, FIXATION, BONE

Model Number	QCKFIX SCRW,TI,CANN ST,CANC.,4.0X 46MM
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/16/2019
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 requested/is expected but has 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 during a subtalar and midfoot fusion procedure, while implanting the ar-8740-46pts low profile screw (lot: 1051702), the upper third shaft of the screw broke off completely.The rep reported the broken head of the screw broke outside of the body and was fully retrieved.The remaining shaft of the screw was left implanted.The rep stated another screw was not brought in, and the case proceeded as planned.The surgeon used two staples laterally to complete the procedure without further issue.The rep stated the broken portion of the screw will be returning for evaluation.Two screws were successfully implanted prior to the breaking of the third ar-8740-46pts.
Additional Manufacturer Narrative
Complaint was confirmed.Visual observations on the returned ar-8740-46pts, revealed a fracture at the distal threaded section of the screw.This is consistent with torsional damage.A critical dimensional measurement was performed at the head and o.D of the screw on the returned device.The device met all specifications as received.The most likely cause for this event includes bending or leveraging the screw, when inserting into the plate and hard bone.

• Brand Name: QCKFIX SCRW,TI,CANN ST,CANC.,4.0X 46MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8588384
• Report Number: 1220246-2019-01082
• Device Sequence Number: 11307662
• Product Code: HWC
• UDI-Device Identifier: 00888867046474
• UDI-Public: 00888867046474
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2019

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 ST,CANC.,4.0X 46MM
• Device Catalogue Number: AR-8740-46PTS
• Device Lot Number: 1051702
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 06/03/2019
• 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