MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,3.5 MINI,34MM LGTH; SCREW, FIXATION, BONE

Model Number	COMPR FT SCRW,3.5 MINI,34MM LGTH
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/20/2019
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 a 3.5x34mm headless ft screw was being used during a navicular stress fracture procedure.The surgeon was trying to drive the screw flush when a portion snapped and part of the screw came out with the driver.The portion that was in bone would have needed to be cored out so the surgeon opted to leave it in as he still got adequate compression.Additional information provided 8/28/2019- the remaining fragment was left in bone as there was no easy way to remove and the surgeon was still confident in the fixation and compression.
Additional Manufacturer Narrative
This submission contains additional information that was obtained 10/8/19.Complaint was confirmed.Visual observations on the returned ar-8730-34h, revealed a fracture right after the taper threaded section of the screw.The returned ar-8730-34h was reviewed for critical dimensions at the head of the screw (major diameter) and minor diameter at the end of the screw.The device met all specifications as received.A most likely cause for this event includes improper bone preparation prior to insertion and bending/leveraging the screw while inserting into hard bone.
Event or Problem Description
It was reported that a 3.5x34mm headless ft screw was being used during a navicular stress fracture procedure.The surgeon was trying the drive the screw flush when a portion snapped and part of the screw came out with the driver.The portion that was in bone would have needed to be cored out so the surgeon opted to leave it in as he still got adequate compression.Additional information provided 8/28/19: the remaining fragment was left in bone as their was no easy way to remove and the surgeon was still confident in the fixation and compression.Additional information provided 10/8/19: while prepping the bone, just the straight drill was used.No profile drill.

• Brand Name: COMPR FT SCRW,3.5 MINI,34MM LGTH
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9081014
• Report Number: 1220246-2019-01317
• Device Sequence Number: 2811653
• Product Code: HWC
• UDI-Device Identifier: 00888867127067
• UDI-Public: 00888867127067
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/15/2019

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,34MM LGTH
• Device Catalogue Number: AR-8730-34H
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 10/15/2019
• 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