MAUDE Adverse Event Report: ARTHREX, INC. FOREFOOT IB IMPLANT SYS, PEEK; SCREW, FIXATION, BONE

Model Number	FOREFOOT IB IMPLANT SYS, PEEK
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/04/2020
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 during a 2nd met transverse plane repair procedure the ar-1530p-cp forefoot ib implant system was being used.After inserting the 3x8mm tenodesis screw into the patient's metatarsal, the inserter from the driver handle broke off and was stuck inside the screw cannulation, which was in the patient.Instruments were used to attempt to retrieve the screw, but did not work.The rep reported further attempts would compromise the repair and patients metatarsal, so the piece was left in the patient.The account has the broken driver in their possession.Additional information received on 02/06/2020: the rep reported the surgery was a primary procedure.The bone quality was medium.No unplanned incisions were necessary as there was adequate exposure in the area where the issue occurred.X-rays were taken and confirmed the broken piece remained in the screw cannulation.The rep stated they would need to obtain approval from the facility in order to send de-identified copies of the x-rays.The facility took the two drivers from the kit and confiscated for their own reporting.The rep provided a picture of the two drivers.

• Brand Name: FOREFOOT IB IMPLANT SYS, PEEK
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9750612
• Report Number: 1220246-2020-01697
• Device Sequence Number: 3029675
• Product Code: HWC
• UDI-Device Identifier: 00888867242081
• UDI-Public: 00888867242081
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/25/2020

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 Expiration Date: 11/30/2024
• Device Model Number: FOREFOOT IB IMPLANT SYS, PEEK
• Device Catalogue Number: AR-1530P-CP
• Device Lot Number: 10499699
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/25/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other