MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,3.5 MINI, 36MM; SCREW, FIXATION, BONE

Model Number	COMPR FT SCRW,3.5 MINI, 36MM
Health Effect - Clinical Codes	Pain (1994); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/24/2020
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
Female patient (unknown age) had a lapidus bunion procedure on her right foot on (b)(6) 2019.She complained of pain and an x-ray showed that the ar-8730-36h screw had broken.There was a second surgery done on (b)(6) 2020 and a partial of the broken screw was removed from the patient.There is a fragment remaining in the middle of the bone intermediate cuneiform.Also removed was the plate ar-8941, screws ar-8935l-16 x2, ar-8935l-18 x1 and ar-8940-22 x1.Nothing else was implanted after the plate and screws were removed.Caller was unaware of any post-op non-compliance.

• Brand Name: COMPR FT SCRW,3.5 MINI, 36MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9695037
• Report Number: 1220246-2020-01652
• Device Sequence Number: 16749773
• Product Code: HWC
• UDI-Device Identifier: 00888867303300
• UDI-Public: 00888867303300
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K182361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/11/2020

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, 36MM
• Device Catalogue Number: AR-8730-36H
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 02/11/2020
• 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