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	01/06/2020
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 a forefoot ib implant system, ar-1530p-cp, was being used in a forefoot ib for hallux varus.After passing the fibertape suture through both bone tunnels, surgeon was fixating the proximal phalanx with the 1st of two provided 3 x 8 tenodesis screws.With the last couple turn(s) of the screw, there was an audible clicking sound and the driver shaft of the 3 x 8 tenodesis screw had broken off flush inside the screw body.The surgeon attempted to remove the piece, but it was determined that the only way to do so would cause more harm to the patient and a loss of fixation.The 3 x 8 screw was used as indicated.It is believed by the rep that the patient had very good bone quality and the driver simply had a little too much torque and snapped off on the last clockwise turn.X-way confirmed that the driver shaft was flush within the peek screw within the bone and no harm is anticipated to the patient.Additional information provided 01/07/2020: there were no other fragments other than the tip that stayed lodged within the implant.The x-rays mentioned previously will not be released by the facility.The driver will be returned.
Additional Manufacturer Narrative
Complaint confirmed, the tip of the driver broke off.Likely causes of the event include continually applying torque when the implant is not advancing or fully seated, improper bone prep, prying/leveraging the device during use.

• 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: 9631329
• Report Number: 1220246-2020-01596
• Device Sequence Number: 2668185
• Product Code: HWC
• UDI-Device Identifier: 00888867242081
• UDI-Public: 00888867242081
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2020

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: 09/30/2024
• Device Model Number: FOREFOOT IB IMPLANT SYS, PEEK
• Device Catalogue Number: AR-1530P-CP
• Device Lot Number: 10420651
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 03/26/2020
• 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