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

Model Number	CLAV FRAC PLT,CENTRAL THIRD,RT,SS
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint confirmed.The plate was received broken in two fragments.Evaluation reveals the plate bent and then broke.The plate was found to meet dimensional and material specification.The most likely cause is the application of an external mechanical load to the plate post-implantation.
Event or Problem Description
It was reported that two months after surgery the patient went to the surgeon for consultation due to pain.An x-ray was performed and it was confirmed that the plate that had been put in the clavicle was broken.It required a second surgery to remove the plate and replace it.Update 12-feb-2019: the second surgery was done a couple weeks ago with the exact not yet determined.Further information requested.Update 13-feb-2019: the first surgery took place on (b)(6) 2018.It was finished successfully without any problem.The plate used was the ar-2653cr with batch number 5261640.A few months after surgery the patient felt pain and came for a consult.They made an x-ray and found that the clavicular plate was broken.A second surgery was performed on (b)(6) 2019.It was performed by the same surgeon as the first surgery.The patient's broken plate was removed and replaced by a new one from the same part number and different batch number (ar-2653cr batch number 5261726).Since the day of the second surgery no complaints have been reported.

• Brand Name: CLAV FRAC PLT,CENTRAL THIRD,RT,SS
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8390325
• Report Number: 1220246-2019-00939
• Device Sequence Number: 1576263
• Product Code: HRS
• UDI-Device Identifier: 00888867027459
• UDI-Public: 00888867027459
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K143139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2019

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 Model Number: CLAV FRAC PLT,CENTRAL THIRD,RT,SS
• Device Catalogue Number: AR-2653CR
• Device Lot Number: 5261640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 03/05/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other