MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP INTERFSCRW CAN-DELTATPR 9X 35MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP INTERFSCRW CAN-DELTATPR 9X 35MM
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
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.Complaint confirmed, the thread is damaged along the 1st cm of the device.The screw is also deformed and warped.The cause of the event is undetermined, however the most likely cause for the reported failure can be attributed to user error due to misaligned insertion and/or improper bone preparation.
Event or Problem Description
It was reported that during an anterior cruciate ligament surgery the screw thread peeled off during the first few turns and it was therefore no longer possible to implant the screw.No part of the device broke off.The diameter of the bone tunnel was 8 mm and the dimensions of the device are 9 mm x 35 mm.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device (8x28 mm; ar-5028c-08).It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: BIO-COMP INTERFSCRW CAN-DELTATPR 9X 35MM
• 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: 19566915
• Report Number: 1220246-2024-06096
• Device Sequence Number: 6112725
• Product Code: MAI
• UDI-Device Identifier: 00888867035508
• UDI-Public: 00888867035508
• 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,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/19/2024

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: 10/31/2024
• Device Model Number: BIO-COMP INTERFSCRW CAN-DELTATPR 9X 35MM
• Device Catalogue Number: AR-5035TC-09
• Device Lot Number: 12135519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2020
• 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