MAUDE Adverse Event Report: ARTHREX, INC. RETROFUSION SCREW, 20MM; SCREW, FIXATION, BONE

Model Number	RETROFUSION SCREW, 20MM
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint confirmed.The proximal end of the screw and the neck were returned with signs of torsional fracture, with the distal end missing.A most likely cause(s) of this type of event include improper bone preparation and over-torquing the implant during insertion.
Event or Problem Description
It was reported that the head of the screw broke-off during insertion; it remains in the patient.This was a hammertoe case on the second toe.(b)(6) male patient.At the first attempt to insert, the surgeon encountered hard bone.He backed out the screw and redrilled the site.At the second attempt, the head broke off.The body of the screw remains in the patient's toe; the surgeon put a pin in the center of the toe next to the screw.

• Brand Name: RETROFUSION SCREW, 20MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8344520
• Report Number: 1220246-2019-00901
• Device Sequence Number: 11162485
• Product Code: HWC
• UDI-Device Identifier: 00888867187825
• UDI-Public: 00888867187825
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K151078
• 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): 02/15/2019

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 Expiration Date: 12/31/2022
• Device Model Number: RETROFUSION SCREW, 20MM
• Device Catalogue Number: AR-4157-20
• Device Lot Number: 10185987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 02/15/2019
• 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
• Patient Age: 40 YR