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	Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	11/12/2020
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 female patient (unknown age) had a clavicle fracture case done on (b)(6) 2020.Post-op, the plate broke in half along the oblong screw hole (unknown if there was an event that caused the break).On (b)(6) 2020, there was a revision case done to remove the plate and it was replaced with another plate (unknown part).
Additional Manufacturer Narrative
It was reported that the clavicle plate had fractured.The reported event is confirmed upon investigation of the returned pictures.Visual evaluation confirmed that the plate had fractured.However, without the return of the device, further investigation cannot be performed.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is excessive forces applied before full healing.

• 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: 11046652
• Report Number: 1220246-2020-02421
• Device Sequence Number: 13751418
• Product Code: HRS
• UDI-Device Identifier: 00888867027435
• UDI-Public: 00888867027435
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K143139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2020

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 12/23/2020
• 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