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 Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	05/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that 4 months after the surgery the device broke postoperative and dislocated.The part of the screw remained in the free joint body and will be removed during revision surgery on (b)(6) 2024.
Additional Manufacturer Narrative
Additional information: b5, d6a, d6b, g3, h3, h6.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Update kpilz 10-oct-2024: further information were received on 03-oct-2024 that the revision surgery occurred on the (b)(6) 2024.Only the broken part of the screw was removed.The part close to the joint remained in the drill channel.The implant is stable.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is confirmed.One unpackaged ar-4030c-09 serial/batch number (b)(6) was received for investigation.Upon visual inspection, it was determined that the fastthread¿ biocomposite¿ interference screw, had sustained significant damage and distortion along the proximal end of the screw.Functional testing was not performed due to the damage of the device.The most likely cause for the reported failure can be attributed to a patient-specific event.

• 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: 20270052
• Report Number: 1220246-2024-07790
• Device Sequence Number: 3469815
• Product Code: MAI
• UDI-Device Identifier: 00888867277663
• UDI-Public: 00888867277663
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K202535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: Ø9X 30MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4030C-09
• Device Lot Number: 15144778
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 10/10/2024; 01/03/2025
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/28/2024; 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown