MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,3.5 MINI, 42MM; SCREW, FIXATION, BONE

Model Number	COMPR FT SCRW,3.5 MINI, 42MM
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/29/2020
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 during an mis bunion procedure (b)(6) 2020.While implanting a second screw the compression ft screw (ar-8730-42h) broke about mid-shaft.Reporter states correct drilling was performed and the patient bone quality was average.All pieces were fully retrieved from the patient.The case was completed using a lapidus plate.No additional unplanned incisions were needed to remove the screw pieces however a bigger incision was needed to put the lapidus plate on.A profile drill for 3.5 screw and a 2.7 drill bit had been used to prep the bone socket.A t-10 cannulated hexalobe driver with a ratcheting handle was used to implant the screw.
Additional Manufacturer Narrative
The reported event is confirmed upon investigation of the returned product.Visual evaluation identified that the screw had fractured in half along the threads.Additionally, the hex feature revealed signs of use and minor stripping of the hex points.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is applying excessive mechanical forces while inserting the device.

• Brand Name: COMPR FT SCRW,3.5 MINI, 42MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10443262
• Report Number: 1220246-2020-02092
• Device Sequence Number: 19827130
• Product Code: HWC
• UDI-Device Identifier: 00888867303331
• UDI-Public: 00888867303331
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K182361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2020

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: COMPR FT SCRW,3.5 MINI, 42MM
• Device Catalogue Number: AR-8730-42H
• Device Lot Number: 10355036
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 08/27/2020
• 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