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

Model Number	CLAV FRAC PLT,CENTRAL THIRD,RT,SS, STRL
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/12/2020
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 approx.3 weeks post op, a clavicula plate broke and needed to be replaced during a revision surgery.Update 25-aug-2020: patient did not suffer from a trauma.The broken arthrex plate was replaced by a plate from another manufacturer.Part numbers of the screws are unknown.They will not be returned for evaluation.Initial surgery was on (b)(6) 2020, revision surgery was on (b)(6) 2020.
Additional Manufacturer Narrative
The reported event is confirmed upon investigation of the returned product.Visual evaluation identified that the plate was fractured in half.Material analysis confirmed that the plate material was 316 ss.The 6 associated screws were reported as unknown screws.Investigation was unable to identify the screws and no apparent malfunction was identified for all screws.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is applying excessive mechanical forces to the plate before full heal.

• Brand Name: CLAV FRAC PLT,CENTRAL THIRD,RT,SS, STRL
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10513496
• Report Number: 1220246-2020-02140
• Device Sequence Number: 3656762
• Product Code: HRS
• UDI-Device Identifier: 00888867195899
• UDI-Public: 00888867195899
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020

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, STRL
• Device Catalogue Number: AR-2655CRS
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 11/06/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other