MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,3.5 MINI,32MM LGTH; SCREW, FIXATION, BONE

Model Number	COMPR FT SCRW,3.5 MINI,32MM LGTH
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2020
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 ankle fracture repair, the surgeon prepped the bone using the 2.7 drill, with k-wire and profile drill.When inserting the first ar-8730-32h, compression screw on power, the driver torqued.The surgeon continued by using a hand driver to advance the screw before it snapped about 2/3 the way in.The surgeon was able to remove the screw using vice grips.The surgeon cleaned the insertion site using a 2.7 drill bit and profile drill a second time to create a cleaner drill hole and remove any bone debris.The surgeon then attempted to insert a second ar-8730-32h compression screw with the hand driver and the screw snapped off in the same location.The surgeon was unable to retrieve the broken part of the screw.The case was completed with the reduction of the fracture not as expected.The issues extended the procedure by one hour.

• Brand Name: COMPR FT SCRW,3.5 MINI,32MM LGTH
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10631200
• Report Number: 1220246-2020-02212
• Device Sequence Number: 11526538
• Product Code: HWC
• UDI-Device Identifier: 00888867127050
• UDI-Public: 00888867127050
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 10/05/2020

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,32MM LGTH
• Device Catalogue Number: AR-8730-32H
• Device Lot Number: 10286748
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 10/05/2020
• 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