MAUDE Adverse Event Report: ARTHREX, INC. CLAVICLE FRACTURE PLATE, CENTRAL THIRD, RIGHT, STAINLESS STEEL; WASHER, BOLT, NUT

Catalog Number	AR-2652CR
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/06/2017
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 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.Device history record review revealed nothing relevant to this event.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.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.
Event or Problem Description
It was reported via medwatch ((b)(4)) that a patient underwent a revision right clavicle osteotomy on (b)(6) 2017 due a broken ar-2652cr clavicle fracture plate which required removal due to malunion.Additional information obtained 02/13/2017: the original surgery date was (b)(6) 2016.Plate was broken post-op.During the revision the surgeon explanted the ar-2652cr clavicle fracture plate ((b)(4)).To remove the broken plate the surgeon also explanted the following screws from the original (b)(6) 2016 surgery: ar-8835l-16 locking screw, ar-8835-20 cortical screw, ar-8835-22 cortical screw, ar-8835-24 cortical screw and ar-8830-20 cancellous screw.The procedure was completed using non-arthrex products.

• Brand Name: CLAVICLE FRACTURE PLATE, CENTRAL THIRD, RIGHT, STAINLESS STEEL
• Common Device Name: WASHER, BOLT, NUT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6368816
• Report Number: 1220246-2017-00054
• Device Sequence Number: 634735
• Product Code: HTN
• UDI-Device Identifier: 00888867027435
• UDI-Public: 00888867027435
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K112437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/01/2017

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-2652CR
• Device Lot Number: 6791328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2017
• Initial Report FDA Received Date: 03/01/2017
• 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