MAUDE Adverse Event Report: ARTHREX, INC. CLAV FRAC PLT,CENTRAL THIRD,LFT,SS; PLATE, FIXATION, BONE

Catalog Number	AR-2655CL
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	02/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (date of birth, 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 event as reported could not be determined as the device was not yet returned for evaluation.The most likely cause of this event is patient non-compliance and failure to follow the post-op rehab 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.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.Device not yet returned by the facility.
Event or Problem Description
It was reported that on (b)(6) 2012, the patient had undergone an initial takedown of malunion and orif procedure for a mid-shaft clavicle fracture with non-arthrex products.Patient had re-fractured at the end of the initial plating and a second orif surgery ((b)(6) 2016) was performed with the same surgeon at the same facility, where the surgeon explanted the clavicle plate and screws (non-arthrex products) and implanted a new clavicle plate, ar-2655cl (lot unknown).No specific incidents were reported to have occurred since the second surgery and it was reported that patient was compliant.Approximately 10 weeks post op from the second repair, patient reported sudden onset of pain while standing.X-rays were taken which confirmed the ar-2655cl clavicle plate had broken in half.A repair surgery date was not set to remove the broken plate and revise the repair; however, a consultation has been scheduled for (b)(6) 2016 with the patient and surgeon to see if the clavicle has been united.Patient is a male, (b)(6).**on (b)(6) 2017: update: rep notified the distributor that the patient had the broken clavicle plate removed in a revision surgery on (b)(6) 2017.The surgeon used a non-arthrex plate for this procedure.The rep was only able to obtain half of the broken clavicle plate which would be returned for evaluation.
Additional Manufacturer Narrative
Patient demographics (date of birth, 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 a follow-up submission due to device evaluation.Lot number was not provided so device history record review cannot be performed.Complaint confirmed.The device met all material specification as received.The evaluation revealed the plate broke approximately at the medial section.The fracture face runs diagonally through one of the lateral oblong holes.Features observed on the fracture surface are typically seen on metal fracture due to metal fatigue from bending stress that exceeded the fatigue strength of the material.In addition, presence of worn- out or post-fracture rubbing damage areas is indicative of low cycle fatigue fracture mode.Based on the event description and observed evidence, the most likely cause for the complainant's event was in-vivo loading of the device possibly causing a fatigue fracture and/or patient non-compliance with the post-op protocol.Per product directions for use (dfu-0192), post-operatively, until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weight bearing or other unsupported stress.The fixation provided by this device should be protected.The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device.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 on (b)(6) 2012, the patient had undergone an initial takedown of malunion and orif procedure for a mid-shaft clavicle fracture with non-arthrex products.Patient had re-fractured at the end of the initial plating and a second orif surgery ((b)(6) 2016) was performed with the same surgeon at the same facility, where the surgeon explanted the clavicle plate and screws (non-arthrex products) and implanted a new clavicle plate, ar-2655cl (lot unknown).No specific incidents were reported to have occurred since the second surgery and it was reported that patient was compliant.Approximately 10 weeks post op from the second repair, patient reported sudden onset of pain while standing.X-rays were taken which confirmed the ar-2655cl clavicle plate had broken in half.A repair surgery date was not set to remove the broken plate and revise the repair; however, a consultation has been scheduled for (b)(6) 2016 with the patient and surgeon to see if the clavicle has been united.Patient is a male, (b)(6).On (b)(6) 2017: update: rep notified the distributor that the patient had the broken clavicle plate removed in a revision surgery on (b)(6) 2017.The surgeon used a non-arthrex plate for this procedure.The rep was only able to obtain half of the broken clavicle plate which would be returned for evaluation.

• Brand Name: CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6371754
• Report Number: 1220246-2017-00047
• Device Sequence Number: 916691
• Product Code: HRS
• UDI-Device Identifier: 00888867027480
• UDI-Public: 00888867027480
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K112437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2017

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-2655CL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2017
• Supplement Report FDA Received Date: 04/05/2017
• 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
• Patient Age: 26 YR