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	12/16/2019
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 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 procedure the surgeon was using the ar-1530p-cp forefoot ib implant system and inserted the 3x8 tenodesis screw in the first metatarsal with a 1.3 tigerlink.As the surgeon was trying to remove the driver from the 3x8mm tenodesis screw, the tip of the driver snapped off and stayed in the tenodesis screw.The surgeon did not remove the tip of the driver that snapped off from the tenodesis screw.After observing, the surgeon decided that they did not want to remove the broken driver tip.The bone was prepped by using the guide wire, and cannulated drill included in the ar-1530p-cp.The guide wire was placed bi-cortical and the cannulated drill was also drilled bi-cortical.The bone quality was very hard.Additional information received on 12/23/2019: the rep reported the remaining driver is available to return for evaluation.The rep stated to their knowledge the surgeon verified that the broken driver tip was not sitting proud of the screw, and made the decision to leave it in the implanted tenodesis screw.The rep does not have access to any x-ray copies.The procedure being performed was an hallux rigidus arthroplasty with arthroflex dermal allograft.

• 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: 9582808
• Report Number: 1220246-2020-01574
• Device Sequence Number: 18955465
• Product Code: HWC
• UDI-Device Identifier: 00888867242081
• UDI-Public: 00888867242081
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K051726
• 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
• Report Date (Section B): 01/13/2020

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: 03/31/2024
• Device Model Number: FOREFOOT IB IMPLANT SYS, PEEK
• Device Catalogue Number: AR-1530P-CP
• Device Lot Number: 10298681
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 01/13/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other