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	Failure of Implant (1924)
Date of Event	08/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported via the patient's legal representative that the patient underwent an open reduction internal fixation of right clavicle fracture procedure on (b)(6) 2018 after the patient had suffered an injury in a motor vehicle collision approximately 5 weeks prior.The operative report from the (b)(6) 2018 procedure notes the patient is a smoker and also notes a high risk of non-union and large displacement greater than 100%.The patient chose to proceed with the procedure and during the procedure the following arthrex product were recorded as having been implanted: ar-2653cr (lot 5261643) ¿ clavicle plate qty 1.Ar-8835-16 (lot 10204570) ¿ low profile screw qty 2.Ar-8835-22 (lot 10034710) ¿ low profile screw qty 1.Ar-8835l-14 (lot w50298) ¿ low profile locking screw qty 2.Ar-8835l-16 (lot 10181718) ¿ low profile locking screw qty 3.Ar-8835l-18 (lot 1194485) ¿ low profile locking screw qty 1.Ar-8835l-22 (lot a43035)¿ low profile locking screw qty 1.On (b)(6) 2018 the patient underwent a revision surgery due to post operative fixation failure.The operative report noted a right clavicle hardware removal and right clavicle open reduction internal fixation with intercalary strut allograft.The operative report does not reference which arthrex devices were removed.Photos provided to arthrex shows an explanted broken plate and 8 screws, not 10.

• 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: 8732551
• Report Number: 1220246-2019-01157
• Device Sequence Number: 2573171
• Product Code: HRS
• UDI-Device Identifier: 00888867027459
• UDI-Public: 00888867027459
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2019

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: 5261643
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 06/25/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR