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

Model Number	COMPR FT SCRW,3.5 MINI,32MM LGTH
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/14/2023, it was reported by a distributor that an ar-8730-32h mini compression ft screw broke.This occurred during a navicular fracture on (b)(6) 2023, where the navicular was properly reduced and drilled.Upon inserting the screw, the first screwdriver used was stripped.A second driver was used but began stripping as well.The extractor/trephine from the ar-8738c set was used to try and remove the screw, but the screw broke.The portion of the broken screw and k-wire remained in the patient as part of the final construct.A dynanite staple was used as well to provide further compression.The doctor noted that the patient had very hard bone quality.
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The method of bone preparation and the quality of the bone encountered were not specified.Per dfu-0110-eo rev 0 section e warnings - the joint or osteotomy should be stabilized prior to insertion of the screw to prevent damage to the screw or inserter.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: COMPR FT SCRW,3.5 MINI,32MM LGTH
• Common Device Name: BONE FIXATION SCREW/PLATE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: emily shafer ; 8009337001
• MDR Report Key: 18505873
• Report Number: 1220246-2024-00332
• Device Sequence Number: 8146191
• Product Code: HRS
• UDI-Device Identifier: 00888867127050
• UDI-Public: 00888867127050
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K201132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: COMPR FT SCRW,3.5 MINI,32MM LGTH
• Device Catalogue Number: AR-8730-32H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown