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

Model Number	CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/09/2020
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 clavicula plate broke post op.The plate was removed during a revision surgery and another plate from another manufacturer was implanted.At the moment, part and batch numbers of the plate and the associated screws are unknown.Further more, the date of the initial surgery and the revision surgery are unknown.Update 17-sep-2020: following information received from patient's solicitor: along with the plate the following screws were used: 3x ar-8835-x (length unknown), and 5x ar-8835l-x (lenght unknown).Patient is male, size 178 cm, (b)(6) kg, yob: (b)(6), retired.He did not ride bike, nor did he move heavy loads, nor was he physically active.Update 21-sep-2020: following update received: initial surgery was performed on (b)(6) 2020.Revision surgery was performed on (b)(6) 2020.

• Brand Name: CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10566981
• Report Number: 1220246-2020-02197
• Device Sequence Number: 2671206
• Product Code: HRS
• UDI-Device Identifier: 00888867027442
• UDI-Public: 00888867027442
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2020

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,LFT,SS
• Device Catalogue Number: AR-2653CL
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 09/22/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 101