MAUDE Adverse Event Report: ARTHREX, INC. BIO-COM INTERFERENCE SCREW, TAPERED TIP; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COM INTERFERENCE SCREW, TAPERED TIP
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
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 due to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.
Event or Problem Description
It was reported that during a posterior cruciate ligament surgery the bone structure has given way during the implantation of the device and no secure fixation of the device was possible.The bone tunnel was initially prepared for a 6x23 mm screw, but a 8x28 mm screw was finally used for a secure fixation.There was no harm or adverse event for patient, operator or third party reported.The surgery was finished successfully with a different device (ar-5028c-08).It was not necessary to switch the surgical technique or do a second surgery.Update avoe 28-jun-2021: it was confirmed that no new bonetunnel had to be drilled.The anchor is usually implanted by hammering the metal button on the bottom until it is flush with the handpiece.It was further confirmed that the metal button of the device broke off.The exact moment when the metal button broke is unclear.Only the front part of the entire device is inside the patient's joint, which means that the breakage point must have been outside of the patient.Nothing had to be retrieved from the patient.Because the metal button had broken off at the bottom, the surgeon had to hit the handpiece to advance the anchor further.After the surgeon hit the handpiece instead of the normal metal button, the tunnel widened slightly.The implants were still stable, but not as deep in the bone tunnel as usual.The surgery was finished successfully with a different device (ar-5028c-08).

• Brand Name: BIO-COM INTERFERENCE SCREW, TAPERED TIP
• 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: 19255738
• Report Number: 1220246-2024-02854
• Device Sequence Number: 20428333
• Product Code: MAI
• UDI-Device Identifier: 00888867014008
• UDI-Public: 00888867014008
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/06/2024

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 Expiration Date: 10/31/2021
• Device Model Number: BIO-COM INTERFERENCE SCREW, TAPERED TIP
• Device Catalogue Number: AR-1360C
• Device Lot Number: 10442079
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2019
• 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