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 Code Available (3191)
Date of Event	10/04/2019
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 a mis bunion procedure, the 3.5mm mini compression screw, ar-8730-42h, broke flush at the medial cortex during insertion.The surgeon left the screw in and inserted a 1.1 k-wire for post-op protocol.No further details, additional information requested.Additional information provided (b)(6) 2019- to prep the bone, the surgeon chose the 3.5 headless ft k-wire, measured, used a straight drill (no profile drill) and then implanted the screw with a driver.During insertion, the screw snapped at the medial cortex.The head of the screw remained cannulated on the k-wire and was able to be removed onto the sterile field.The patient's bone was of medium quality.The k-wire poking out of the foot is a normal post op protocol depending on the procedure, but it wasn¿t the initial plan for this mis bunion procedure.The k-wire will stay in the foot for approximately 6-8 weeks.

• 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: 9225785
• Report Number: 1220246-2019-01374
• Device Sequence Number: 344079
• Product Code: HWC
• UDI-Device Identifier: 00888867303331
• UDI-Public: 00888867303331
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K182361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/23/2019

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/23/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other