MAUDE Adverse Event Report: ARTHREX INC. CLAVICLE FRACTURE PLATE,CENTRAL THIRD,RT,SS; WASHER, BOLT NUT

Catalog Number	AR-2653CR
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/20/2017
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.The device was received and an evaluation was conducted.The complaint was confirmed.Device history record review revealed nothing relevant to this event.The evaluation revealed that the plate broke approximately at the clavicle distal or shoulder side.The fractured face runs diagonally through one of the lateral oblong holes.Plate is bent where fracture occurred.Fractured surface is rough, uniform, and have a polished appearance.The most likely cause(s) of this type of event include patient non-compliance to the post-op protocol or post-op trauma to the surgical site.The directions for use for the device states: post-operatively and 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 post-operative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device.This is the first complaint of this type for this part/lot combination.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 by the representative that per male patient statement, he was on the treadmill running normally and clavicle plate snapped in half.Follow-up investigation: the original surgery date was (b)(6) 2017.Surgeon stated that the treadmill incident was several weeks prior to the revision surgery which took place on (b)(6) 2017.To complete the revision procedure another manufacturer's plate was implanted.During the revision surgery the following screws were also explanted: ar-4160-35 lot 031617 qty 1, ar-8835-12 lot 031724 qty 1, ar-8835-14 lot 10144071 qty 3, ar-8835-16 lot 031716 qty 4, and ar-8835-16 lot 031724 qty 1.

• Brand Name: CLAVICLE FRACTURE PLATE,CENTRAL THIRD,RT,SS
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7108005
• Report Number: 1220246-2017-00468
• Device Sequence Number: 19099825
• Product Code: HTN
• UDI-Device Identifier: 00888867027459
• UDI-Public: 00888867027459
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K112437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/12/2017

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-2653CR
• Device Lot Number: 5261643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2017
• Initial Report FDA Received Date: 12/12/2017
• 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