MAUDE Adverse Event Report: ARTHREX, INC. Ø8X 30MM BC IF SCRW, VENTED; BIO SOFT TISSUE FIXATN FASTNR

Model Number	Ø8X 30MM BC IF SCRW, VENTED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complain allegation is confirmed based on the customer attached picture.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 that the allegation on the ar-4030c-08 was confirmed, and the reported failure is most likely related to a user error due to improper bone preparation, misaligned insertion, and/or prying/levering the device during insertion.Direction for use.Dfu-0111-eor2_fmt_en.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.
Event or Problem Description
On 11/11/2024, it was reported by a distributor via email that an ar-4030c-08 fastthread biocomposite interference screw broke in the middle during insertion.This was discovered during a procedure on (b)(6) 2024.Additional information received on 11/15/2024: this was discovered during an acl reconstruction surgery.All the broken fragments were successfully retrieved.The case was completed using another ar-4030c-08 fastthread biocomposite interference screw.The case was not delayed as the new screw was readily available.

• Brand Name: Ø8X 30MM 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: jared engle ; 8009337001
• MDR Report Key: 20892125
• Report Number: 1220246-2024-08771
• Device Sequence Number: 15622008
• Product Code: MAI
• UDI-Device Identifier: 00888867277656
• UDI-Public: (01)00888867277656(11)231115(17)271031(10)15168255
• Combination Product (Y/N): N
• Initial Reporter Country: BL
• PMA/510(K) Number: K202535
• 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
• Report Date (Section B): 12/10/2024

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: Ø8X 30MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4030C-08
• Device Lot Number: 15168255
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2023
• 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