MAUDE Adverse Event Report: ARTHREX, INC. LOCKING SCREW, TITANIUM 3.5MM X 14MM; SCREW, FIXATION, BONE

Model Number	LOCKING SCREW, TITANIUM 3.5MM X 14MM
Health Effect - Clinical Codes	Pain (1994); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/15/2019
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 device was reported to have been discarded.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 the driver tip broke off in the screw during removal of a lapidus plate.Additional information obtained (b)(6) 2019: the patient¿s original implant case was a lapidus procedure.The explant procedure, which was a removal of a lapidus plate and screws, took place on (b)(6) 2019.Devices were being explanted due to patient pain.Date of original lapidus surgery has not been provided at this time.The following devices were explanted during the (b)(6) 2019 procedure: ar-8941 lapidus plate (qty 1); ar-8935l-14 locking screw, (qty 1); ar-8935l-16 locking screw (qty 2); and ar-8935-16 cortical screw (qty1).After the driver tip broke the surgeon chose to not explant the 4.0 headless screw and it remains in the patient¿s body.No fragments of the broken driver were left in the patient.

• Brand Name: LOCKING SCREW, TITANIUM 3.5MM X 14MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8317055
• Report Number: 1220246-2019-00883
• Device Sequence Number: 19277605
• Product Code: HWC
• UDI-Device Identifier: 00888867050853
• UDI-Public: 00888867050853
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• 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): 02/07/2019

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 Model Number: LOCKING SCREW, TITANIUM 3.5MM X 14MM
• Device Catalogue Number: AR-8935L-14
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 02/07/2019
• 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