MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO MTP PLT TM CONTRD,SHT,R,TI; PLATE, FIXATION, BONE

Catalog Number	AR-8944CR-P
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	09/30/2016
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.The device was requested for evaluation but was not returned, 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.Device history record review revealed nothing relevant to this event.A most likely cause of the plate breaking post-op is patient non-compliance with the post-op protocol.The directions for use states: post-operatively, until healing is complete the fixation provided by this device should be protected.The post-operative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the implant.This is the first complaint of this type for this part/lot combination.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.Facility will not release the device.
Event or Problem Description
It was reported that the ar-8944cr-p was being used in a first metatarsal phalangeal joint fusion.The procedure took place on (b)(6) 2016, and was completed successfully.Approximately 2-3 months after the procedure, the patient was walking and felt the plate pop.She was also feeling a little discomfort.She went and saw the doctor who performed the surgery since she was concerned something broke.The doctor took an x-ray and confirmed that the plate was broken in half.A revision surgery was performed (b)(6) 2016 and this plate was removed.During the surgery, the surgeon felt that another plate was not necessary since the fusion was complete.Patient is doing well post op.

• Brand Name: LO-PRO MTP PLT TM CONTRD,SHT,R,TI
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6349902
• Report Number: 1220246-2017-00041
• Device Sequence Number: 10976074
• Product Code: HRS
• UDI-Device Identifier: 00888867052987
• UDI-Public: 00888867052987
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K052614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 02/22/2017

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-8944CR-P
• Device Lot Number: 10030273
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2017
• Initial Report FDA Received Date: 02/22/2017
• 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