MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP INTERFSCRW,FULL THD; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP INTERFSCRW,FULL THD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2022
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 is confirmed.One unpackaged ar-1380tc serial/batch number (b)(6) was received for investigation.Visual evaluation found that the full thread cannulated biocomposite interference screw, 8 x 28 mm, is broken into three pieces, and the screw head is completely damaged.The most likely cause for the reported failure can be attributed to environmental due to damage incurred during shipping.However, due to the device being unpackaged when returned, we are unable to confirm the reported event.
Event or Problem Description
On 10/20/2022, it was reported by an arthrex employee via email that an ar-1380tc full thread cannulated biocomposite interference screw broke.Another new product was used, and case was completed.Additional information received on 10/24/2022: this was discovered upon opening package prior to a procedure, the screw was found broken.Another ar-1380tc full thread cannulated biocomposite interference screw, from the same lot number was used to complete the case.

• Brand Name: BIO-COMP INTERFSCRW,FULL THD
• 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: 19254671
• Report Number: 1220246-2024-02852
• Device Sequence Number: 17969475
• Product Code: MAI
• UDI-Device Identifier: 00888867015357
• UDI-Public: 00888867015357
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K071176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• 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 Model Number: BIO-COMP INTERFSCRW,FULL THD
• Device Catalogue Number: AR-1380TC
• Device Lot Number: 12915076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2022
• Initial Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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