MAUDE Adverse Event Report: ARTHREX, INC. Ø10X 20MM BC IF SCRW, VENTED; BIO SOFT TISSUE FIXATN FASTNR

Model Number	Ø10X 20MM BC IF SCRW, VENTED
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery the screws lost their shape and fell apart when being implanted.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
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, h3, h6.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex concluded that the most likely cause.The most likely cause of the reported failure is user error, specifically improper bone preparation, misalignment during insertion, and/or incorrect alignment of the screwdriver with the screw to a fully seated position, which could potentially damage the implant.Directions for use (dfu) 0111-7 interferences screws.G.Precautions.6.Bio-absorbable interference screw only: it is important to completely seat the screwdriver to prevent potential stripping of the hex and/or screw fracture during insertion or removal.The complaint allegation was confirmed based on the customer¿s attached pictures, which show two ar-4020c-10 devices with stripped and damaged threads.
Event or Problem Description
Update nroe 25-jan-2024: further information was provided and revealed that the incident occurred during an anterior cruciate ligament reconstruction surgery.The surgery was finished successfully with a new device from another manufacturer.

• Brand Name: Ø10X 20MM BC IF SCRW, VENTED
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 18582087
• Report Number: 1220246-2024-00545
• Device Sequence Number: 7021430
• Product Code: MAI
• UDI-Device Identifier: 00888867276987
• UDI-Public: 00888867276987
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K202535
• 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
• Report Date (Section B): 05/06/2025

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: Ø10X 20MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4020C-10
• Device Lot Number: 15076305
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2023
• 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