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

Catalog Number	AR-2653CL
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/02/2018
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.Device history record review revealed nothing relevant to this event.The explanted device was requested for evaluation but was not returned.The cause of the event could not be determined from the information available and without device evaluation.There were no adverse patient consequences reported as a result of this event.The most likely cause of this event is failure to follow the post-op rehab protocol.The device's 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 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 initially reported that rep was told of two cases of post-op clavicle plate breakage at 4-6 weeks post op.No further details were available at time of initial report.Follow-up investigation: patient underwent an orif clavicle procedure on (b)(6) 2018.Four weeks post op it was discovered that the ar-2653cl lot 6791303 plate had broken.It was reported to the sales rep by the surgeon that the patient did not suffer any trauma or injury post the original surgery/prior to discovering the broken plate.A revision surgery has been performed at the same facility on (b)(6) 2018.During the revision the broken ar-2653cl was explanted along with the screws.The devices were discarded after the case.The procedure was completed by using another manufacturers clavicle plate.The following screws were also explanted at the time of revision: ar-8835-16 (qty 4) lot 031716, ar-8835-12 (qty1) lot 031724, ar-8835-18 (qty 2) lot w49116, ar-8835-14 (qty 1) lot 031724, ar-8835l-14 (qty 2) lot 031722, ar-8835l-16 (qty 1) lot w47694.

• Brand Name: CLAVICLE FRACTURE PLATE,CENTRAL THIRD,LEFT,SS
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7439299
• Report Number: 1220246-2018-00143
• Device Sequence Number: 16417588
• Product Code: HTN
• UDI-Device Identifier: 00888867027442
• UDI-Public: 00888867027442
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 04/18/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: AR-2653CL
• Device Lot Number: 6791303
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2018
• Initial Report FDA Received Date: 04/18/2018
• 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