MAUDE Adverse Event Report: ARTHREX, INC. Ø11X 30MM BC IF SCRW, VENTED; BIO SOFT TISSUE FIXATN FASTNR

Model Number	Ø11X 30MM BC IF SCRW, VENTED
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user error of the device due to over-torqueing/over-engaging the driver with the screw head.
Event or Problem Description
On 3/9/2023, it was reported by a sales representative via email that an ar-4030c-11 fastthread biocomposite interference screw got stuck to a screwdriver and pulled out when the driver was being removed.This was discovered during an aclr procedure on (b)(6) 2023.A new ar-4030c-11 fastthread biocomposite interference screw was used to complete the case.Additional information received on 3/13/2023: when the surgeon removed the screwdriver from inside the patient and the screw pulled out, the surgeon had to break up the screw to remove it from the driver entirely.Nothing broke inside the patient as the surgeon broke the screw after it was removed from the patient.

• Brand Name: Ø11X 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: 19495263
• Report Number: 1220246-2024-05338
• Device Sequence Number: 18339324
• Product Code: MAI
• UDI-Device Identifier: 00888867277687
• UDI-Public: 00888867277687
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K202535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/09/2024

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: Ø11X 30MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4030C-11
• Device Lot Number: 15029945
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 06/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2022
• 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