MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,2.5 MICRO, 50MM; SCREW, FIXATION, BONE

Model Number	COMPR FT SCRW,2.5 MICRO, 50MM
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/27/2019
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 metatarsal fracture repair procedure, the surgeon prepared the insertion site using a 2.2 drill, the ar-8725-50h screw was inserted, as the surgeon made the final turns, to countersink the screw it broke approximately 19-20 mm from the drive insertion point.The surgeon used an ar-8737-61, easy out tool, on power to try and release the screw and the tip of the driver broke.The portion of the screw with the driver insertion was removed.The remainder of the screw was left in with the tip of the easy out tool still in the cannulation of the screw.The case was completed with the remainder of the screw still across the fracture site with the fracture reduced.Additional information obtained 01/06/2020: the screw broke but the driver for the screw did not break.The extraction tool broke later in the procedure.The remaining 30 mm of the screw was left in the patient, still across the fracture site, with the tip of the easy out tool in the screw's cannulation.The surgeon did not need to use any additional screws or additional incisions.It was a metacarpal fracture and there were limited access points.The surgeon did not need to do anything additional that was unplanned.The fracture was reduced by the remaining 30 mm piece of screw.The only additional part of the procedure was the attempted unsuccessful removal with the easy out tool.

• Brand Name: COMPR FT SCRW,2.5 MICRO, 50MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9607409
• Report Number: 1220246-2020-01584
• Device Sequence Number: 14057577
• Product Code: HWC
• UDI-Device Identifier: 00888867303485
• UDI-Public: 00888867303485
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K182361
• 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): 01/20/2020

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: COMPR FT SCRW,2.5 MICRO, 50MM
• Device Catalogue Number: AR-8725-50H
• Device Lot Number: 10346289
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/20/2020
• 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