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 Information (3190)
Date of Event	08/23/2017
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.Device history record review revealed nothing relevant to this event.The device was requested for evaluation but was discarded 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.As stated in the event, the patient's original surgery was (b)(6) 2017; when he picked up his child ((b)(6)lbs), he felt something snap, the plate had broken.(initial and second surgery were 10 days apart).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 that the patient's original surgery was (b)(6) 2017; when he recently picked up his child ((b)(6) lbs), he felt something snap.The plate had broken.On (b)(6) 2017, there was a second surgery, the plate was removed and another manufacturer's plate was inserted.Caller was not in either case, had no further patient info or the reason for the original case.The broken plate was discarded.Follow-up investigation: original implantation surgery took place on (b)(6) 2017, not (b)(6) 2017 as initially reported.Follow-up investigation: the clavicle plate was part number ar-2653cl, lot 6791303.During the (b)(6) 2017 procedure the following screws were also explanted: ar-8835-12 lot 95241630 qty 1, ar-8835-16 lot 95241717 qty 1, ar-8835l-16 lot f53610 qty 4, ar-8835l-18 lot 10034770 qty 2, ar-2265-14h lot 135138 qty 1 and ar-2665-16h lot 135139 qty 1.

• 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: 7033767
• Report Number: 1220246-2017-00440
• Device Sequence Number: 977982
• Product Code: HTN
• UDI-Device Identifier: 00888867027442
• UDI-Public: 00888867027442
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K112437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 11/15/2017

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-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: 10/27/2017
• Initial Report FDA Received Date: 11/15/2017
• 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