MAUDE Adverse Event Report: ARTHREX, INC. COMPRESSION FT SCREW; SCREW, FIXATION, BONE

Catalog Number	AR-8730-34H
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.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.Lot number was not provided therefore device history record cannot be investigated.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.The most likely cause of this event is improper bone preparation and/or surgical technique.Device remains in patient.
Event or Problem Description
It was reported that during a metatarsal phalngeal fusion (first metatarsal and proximal phlanx) the ar-8730-34h compression ft screw,.5 mini, 34 mm length had broken in half.This issue was discovered upon radiographical examination during the procedure.The broken screw was left in the patient.It was reported that the mtp fusion plate provided great compression despite the screw breaking.No additional screw was needed due to the screw breakage.The case was completed successfully without any additional incisions.No patient injury reported.

• Brand Name: COMPRESSION FT SCREW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 5896897
• Report Number: 1220246-2016-00345
• Device Sequence Number: 13583672
• Product Code: HWC
• UDI-Device Identifier: 00888867127067
• UDI-Public: 00888867127067
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/03/2016

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-8730-34H
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2016
• Initial Report FDA Received Date: 08/23/2016
• 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