MAUDE Adverse Event Report: ARTHREX INC. LOW PROFILE SCREW,CORTICAL,3.5X16MM,DRP; SCREW, FIXATION, BONE

Catalog Number	AR-8735-16
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/21/2018
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, so device history record review cannot be performed.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 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 distal radius procedure, upon insertion of the very first 3.5 mm low profile cortical screw, this screw head came off.The head of the screw was retrieved however, the body of the screw was unable to be removed.The case was completed without further incident.Follow-up investigation: the surgeon attempted to remove the body of the screw with the driver initially but with no success, he switched to a needle driver.Still, the body of the screw could not be removed and was left in the patient sitting flush with the bone.5.The case was completed with a 3.5 size 14 locking screw proximally and a 3.5 cortical screw size 14 in the 3 hole plate.In the distal portion, the plate was filled with 2.4 val screws sizes 16, 18, 18, and 20.

• Brand Name: LOW PROFILE SCREW,CORTICAL,3.5X16MM,DRP
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7521501
• Report Number: 1220246-2018-00181
• Device Sequence Number: 1425177
• Product Code: HWC
• UDI-Device Identifier: 00888867288324
• UDI-Public: 00888867288324
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K103705
• 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): 05/17/2018

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-8735-16
• 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: 04/25/2018
• Initial Report FDA Received Date: 05/17/2018
• 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