MAUDE Adverse Event Report: ARTHREX, INC. Ø9X 30MM BC IF SCRW, VENTED; BIO SOFT TISSUE FIXATN FASTNR

Model Number	Ø9X 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	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 7th july 2025, it was reported by an arthrex's employee via email that for an ar-4030c-09, fastthread¿ biocomposite¿ interference screw 9 x 30 mm, the anchor broke during insertion.This was detected during a reconstruction of anterior cruciate ligament surgery on (b)(6) 2025.The procedure was completed successfully by using another new ar-4330c-09.There was no patient harm and no secondary procedure needed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.-one unpackaged ar-4030c-09, fastthread¿ biocomposite¿ interference screw 9 x 30 mm, batch number 15322343, was received for investigation.-upon visual inspection, it was noted that the screw was broken at the distal end.-functional testing was not performed due to the damage to the device.The most likely cause of the reported failure can be attributed to misaligned insertion or prying/leveraging the device during insertion.-refer to investigation photos.-the complaint allegation is confirmed.

• Brand Name: Ø9X 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: 22637949
• Report Number: 1220246-2025-03118
• Device Sequence Number: 18526104
• Product Code: MAI
• UDI-Device Identifier: 00888867277663
• UDI-Public: (01)00888867277663(11)240925(17)280831(10)15322343
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/26/2025

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: Ø9X 30MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4030C-09
• Device Lot Number: 15322343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 07/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown