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	05/12/2020
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 on (b)(6) 2020, during a first mtp interpositional arthroplasty with arthroflex procedure, the screwdriver broke while implanting the peek screw into the met head.The screw was completely advanced and when the surgeon attempted to pull the driver out, the metal shaft snapped.The metal shaft was left in the patient as the screw was flush and it would have done more damage trying to get it out.Attempt was made to retrieve it with a pickup but was unsuccessful.It is buried within the peek screw and is only visible on x-ray.A picture of the broken screw driver has been provided to arthrex.Additional information provided 5/26/2020: the device is part of a forefoot internal brace kit (part number not provided).The entire shaft at the end of the screwdriver was left in the screw inside the patient.Bone had been prepped with a 2.5 drill bit per the guidelines of the arthrex technique guide.Remaining portion of the screwdriver will be returned for evaluation.Additional information provided 6/1/2020: the following is the part and lot number of the device involved: ar-1530-cp, lot 10499699.

• 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: 10183985
• Report Number: 1220246-2020-01903
• Device Sequence Number: 16826678
• Product Code: HWC
• UDI-Device Identifier: 00888867242081
• UDI-Public: 00888867242081
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 06/23/2020

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: FOREFOOT IB IMPLANT SYS, PEEK
• Device Catalogue Number: AR-1530P-CP
• Device Lot Number: 10499699
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 06/23/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other