MAUDE Adverse Event Report: ARTHREX INC. COMPRESSION FT SCREW,3.5 MINI,24MM LGTH; SCREW, FIXATION, BONE

Catalog Number	AR-8730-24H
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Lot number was not provided so device history record review cannot be performed.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a navicular fracture case, the surgeon pre-drilled with a 2.7 drill bit for a 3.5 headless screw.During insertion, the screw broke about 10mm into the navicular.The surgeon was unable to drive the screw out or remove it.About 14mm of the screw was left in the bone and the surgeon ended up opening a synthes small fragment tray and used a 4.0mm screw from there.Patient is female.

• Brand Name: COMPRESSION FT SCREW,3.5 MINI,24MM LGTH
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7600188
• Report Number: 1220246-2018-00224
• Device Sequence Number: 19230126
• Product Code: HWC
• UDI-Device Identifier: 00888867127012
• UDI-Public: 00888867127012
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 06/14/2018

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 Catalogue Number: AR-8730-24H
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 06/14/2018
• 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