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	Bone Fracture(s) (1870)
Date of Event	01/07/2020
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 the plate fracture clavicle occurred five weeks after the primary implantation in a young, healthy patient with an acute fracture.It was further reported that the plate was not pre-bent.The broken plate shows that a plastic deformity occurred before the fracture.Additional information 10-jan-2020.It was further reported that the osteosynthesis clavicle surgery was initially successfully performed in (b)(6) 2019.Due to the initially reported event a reosteosynthesis with a synthesis plate was needed and the revision surgery was performed successfully on (b)(6) 2019.
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, post-op noncompliance prior to full bone healing.Per surgical technique, bending the plate with excessive acute angles may potentially lead to plate fatigue, failure, and/or breakage in-situ.

• 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: 9631338
• Report Number: 1220246-2020-01600
• Device Sequence Number: 19625831
• Product Code: HRS
• UDI-Device Identifier: 00888867027473
• UDI-Public: 00888867027473
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2020

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-2654CR
• Device Lot Number: 5261917
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 03/13/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other