MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO LOCK SCRW,TI,3.0MMX 12MM; PLATE, FIXATION, BONE

Catalog Number	AR-8933L-12
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/09/2017
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.This is one of four submissions from the same incident.The others are (b)(4).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 cause(s) of this event will be 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 the patient underwent a lapidus bunionectomy on (b)(6) 2015 (b)(6) medical center in which a plate and 5 screws were implanted in her left foot.The patient began to experience foot pain beginning in the incision area and radiating outward in (b)(6) 2017.The patient is scheduled to have the plate and 5 screws explanted on (b)(6) 2017 as the bone has fused.Follow investigation: surgeon performed a second surgery on (b)(6) 2017 where he explanted the following devices which had been implanted during the (b)(6) 2015 procedure: ar-8952tt-03 qty 1, ar-8933l-14 qty 2, ar-8933l-12 qty 2, ar-8933l-24 qty 1.The patient also had an ar-8730-34h fully threaded mini compression screw from the original procedure that the surgeon chose to leave in the patient.During the (b)(6) 2017 surgery, the surgeon was using a hexalobe driver to remove the screws and the tip of the driver broke off.The tip was retrieved with forceps and the case was completed.

• Brand Name: LO-PRO LOCK SCRW,TI,3.0MMX 12MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6714792
• Report Number: 1220246-2017-00259
• Device Sequence Number: 16455466
• Product Code: HRS
• UDI-Device Identifier: 00888867050006
• UDI-Public: 00888867050006
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K123241
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2017

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-8933L-12
• 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: 06/27/2017
• Initial Report FDA Received Date: 07/14/2017
• 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