MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,2.5 MICRO, 50MM; SCREW, FIXATION, BONE

Model Number	COMPR FT SCRW,2.5 MICRO, 50MM
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint confirmed, a fragment 0.2155 in length of the proximal end of ar-8725-50h was returned.The most likely cause(s) of this type of event include continually applying torque after the screw is fully seated, torquing when the implant is not properly aligned, and/or not fully seating the driver into the screw during tightening.
Event or Problem Description
It was reported that during a right hand arthroscopy procedure, the surgeon was inserting a micro compression screw, ar-8725-50h, with a 1.5 mm hex driver, ar-8737-37.Upon inserting into the 4th metacarpal, the tip of the hex driver broke off into the head of the compression screw and the screw bent.The screw was removed and the surgeon placed a synthes plate instead.The tip of the driver was removed from the head and fell onto the floor.The surgeon moved on the next step and tried again with a second micro compression screw, ar-8725-50h, and driver.The surgeon started on power with the driver on the end of it and then finished up with a ratcheting handle.Upon insertion of this screw into the 3rd metacarpal, about 8 mm of the head of the screw snapped off leaving aprox.42 mm of the screw in the tunnel.This portion of the screw was not removed from the tunnel.The surgeon was not satisfied with the fixation and used a synthes screw to lag across the fracture site.

• Brand Name: COMPR FT SCRW,2.5 MICRO, 50MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9081390
• Report Number: 1220246-2019-01323
• Device Sequence Number: 2657498
• Product Code: HWC
• UDI-Device Identifier: 00888867303485
• UDI-Public: 00888867303485
• 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
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2019

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,2.5 MICRO, 50MM
• Device Catalogue Number: AR-8725-50H
• Device Lot Number: 10302303
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 09/18/2019
• 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