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	08/09/2019
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 by the sales rep, that during a right foot, planter plate fixation procedure, the surgical resident prepped the surgical site using a 2.5 drill and ar-7521, (suture tape) the resident was using the ar-1530p-cp, (lot #10298681) forefoot ib implant system to implant the 3 x 8 peek tenodesis screw.The screw was seated properly.Upon removal of the driver it was noticed that the tip of the driver had broken off and was left in the screw.The surgeon tried to remove the driver tip using k-wire and a drill however, the surgeon was not successful in retrieving the driver tip from the screw leaving the tip inside the patient.The surgeon was satisfied that the 3 x 8 peek tendonsis screw was secure.The surgical resident completed the procedure with no additional issues.The rep stated there were pictures confirming the driver tip was in the screw.

• 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: 8932510
• Report Number: 1220246-2019-01280
• Device Sequence Number: 1948982
• 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
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/26/2019

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 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: 08/09/2019
• Initial Report FDA Received Date: 08/26/2019
• 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
• Patient Age: 69 YR