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 Codes	Failure of Implant (1924); Pain (1994)
Date of Event	01/21/2020
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 that a patient had undergone a total knee replacement and a week later on (b)(6) 2019 the patient states he got up during the night and blacked out (possibly due to medication being taken as a result of his knee replacement procedure) causing him to fall which caused a fractured clavicle.The patient underwent a surgery on (b)(6) 2019 during which an arthrex clavicle plate ar-2652cr (lot 5261748) and 7 screws (ar-8835l-14 (qty 2), ar-8835l-16 (qty 2), ar-8835-14 (qty 1) and ar-8835-16 (qty 2)) were implanted.The patient reported that he was not experiencing any pain after the surgery until approximately 4 weeks post op when he began to experience pain in the surgical area which he reported was about a 3-4 out of 10.The patient had a planned follow up appointment with the surgeon scheduled for (b)(6) 2020 so he chose to wait until the follow up to discuss with surgeon.The day before his appointment he began experiencing shooting pain at a level of 9 out of 10.At the (b)(6) follow up appointment x-rays were taken which showed the screws in place but the clavicle plate appeared to be shaped like a v.This (b)(6) x-ray was compared to the original post-op x-ray and it was determined that the plate had bent/ broken post op.The bend/ brake was located immediately over the original fracture site.The patient underwent a revision surgery on (b)(6) 2020 during which the original arthrex clavicle plate and screws were explanted.The plate and screws have been returned to arthrex for device evaluation.
Additional Manufacturer Narrative
Complaint confirmed, the plate broke in two near the middle oblong hole.Evaluation shows the plate was bent about 30 degrees before breaking.Likely causes include not following proper surgical technique, repeated bending of the plate at the same location or by creating excessive acute angles that may potentially lead to plate fatigue, failure, and/or breakage in situ, post-op non-compliance prior to full bone healing, non-union of the clavicle.

• 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: 9717451
• Report Number: 1220246-2020-01666
• Device Sequence Number: 16234796
• Product Code: HRS
• UDI-Device Identifier: 00888867027435
• UDI-Public: 00888867027435
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2020

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-2652CR
• Device Lot Number: 5261748
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AR-8835-14 (QTY 1); AR-8835-16 (QTY 2); AR-8835L-14 (QTY2); AR-8835L-16 (QTY 2)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR