MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,4.0 STD,50MM LGTH; BONE FIXATION SCREW/PLATE

Model Number	COMPR FT SCRW,4.0 STD,50MM LGTH
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/5/2023, it was reported by an arthrex subsidiary employee via email that an ar-8740-50h standard compression ft broke during insertion.This was discovered during a procedure on (b)(6) 2023.
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: b5, g3, h6.
Event or Problem Description
Additional information received on 10/17/2023: the case was completed using another ar-8740-50h standard compression ft.The case was not delayed, and additional anesthesia was unnecessary.The patient suffered no negative effects.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is confirmed.Visual inspection identified that the overall length of the mini compression ft¿, titanium, 3.5 mm x 50 mm, had broken into two parts.The threads of the screw were stripped/damaged.Dimensional testing of the major ø.161 ±.005 per drawing c16498-18 was between tolerances.Functional testing was not performed due to the damage to the device.The most likely cause of the reported failure can be attributed to user error of the device due to improper bone preparation and/or prying/leveraging and/or excessive force being used during insertion of the screw.

• Brand Name: COMPR FT SCRW,4.0 STD,50MM 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: 17994833
• Report Number: 1220246-2023-08326
• Device Sequence Number: 6754631
• Product Code: HWC
• UDI-Device Identifier: 00888867127937
• UDI-Public: 00888867127937
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K201132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2024

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,4.0 STD,50MM LGTH
• Device Catalogue Number: AR-8740-50H
• Device Lot Number: IMS000803
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2023
• Supplement Date Received by Manufacturer: 10/17/2023; 10/09/2024
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 05/01/2024; 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2020
• 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