MAUDE Adverse Event Report: ARTHREX INC. LOCKING LATERAL HOOK PLATE, 5 HOLE, SS; PLATE, FIXATION, BONE

Catalog Number AR-8943TH-05

Device Problem Break (1069)

Patient Problems Bradycardia (1751); Fatigue (1849); Anxiety (2328); Palpitations (2467)

Event Date 02/01/2014

Event Type  Injury  

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 six submissions for the same event which 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.A possible cause of this type of event may be a reaction of the patient to the material(s) implanted or used during the implant procedure.Product directions for use warns of effects like foreign body and allergic-like reactions as well as infections both deep and superficial to the implant materials.Patient sensitivity to materials must be considered prior to implantation.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 Description

It was reported by a dermatologist's office that a patient is concerned he is allergic to a component of the plate and screws used to fix his ankle in 2015 after he suffered a break.Reporter has requested material composition of the devices.The following are the implanted devices: ar-8943th-05, locking lateral hook plate, stainless steel ((b)(4)).Ar-8835-30, low profile cortical screw, stainless steel ((b)(4)).Ar-8835-18, low profile cortical screw, stainless steel ((b)(4)).Ar-8835-14, low profile cortical screw, stainless steel ((b)(4)).Ar-8840-14, low profile cancellous screw, stainless steel ((b)(4)).Ar-8926ss, knotless tightrope syndesmosis repair implant.Follow-up investigation: patient's original surgery was in (b)(6) 2014 (not 2015 as originally reported).Specific date is unknown.Surgery was an orif of the left ankle.Patient is a male with known allergy to amoxicillin.Patient has been experiencing chronic fatigue and sleepiness, anxiety and palpitations and bradycardia.Treatments to date are unknown.Material composition of the implanted devices has been provided the reporter.Devices are stainless steel.Since a specific day for the original (b)(6) 2014 surgery is unknown, (b)(6) 2014 will be entered as date of event.

• Brand Name: LOCKING LATERAL HOOK PLATE, 5 HOLE, SS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath, adverse events ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337013
• MDR Report Key: 7285136
• MDR Text Key: 100535223
• Report Number: 1220246-2018-00057
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867052819
• UDI-Public: 00888867052819
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123241
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: AR-8943TH-05
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2018
• Initial Date FDA Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other