MAUDE Adverse Event Report: ARTHREX, INC. FIBULOCK IMPLANT SYSTEM, STERILE; INTRAMED FIXATN ROD AND ACCESS

Model Number	FIBULOCK IMPLANT SYSTEM, STERILE
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2022
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.The most likely cause for the reported failure can be attributed to a manufacturing issue; however, due to the device not being returned, we are unable to confirm the reported event.
Event or Problem Description
On 10/26/2022, it was reported by a sales representative via email that an ar-8973ds fibulock implant system package with sterile instrument, was not sealed, and all the drill bits fell on the floor.This was discovered prior to use during an unspecified procedure.Additional information received on 10/28/2022: this was discovered during a fibulock procedure on (b)(6) 2022 and was completed with a new ar-8973ds fibulock implant system.

• Brand Name: FIBULOCK IMPLANT SYSTEM, STERILE
• Common Device Name: INTRAMED FIXATN ROD AND ACCESS
• 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: 19400163
• Report Number: 1220246-2024-03979
• Device Sequence Number: 15528594
• Product Code: HSB
• UDI-Device Identifier: 00888867303041
• UDI-Public: 00888867303041
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K160069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/27/2024

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: FIBULOCK IMPLANT SYSTEM, STERILE
• Device Catalogue Number: AR-8973DS
• Device Lot Number: 1500154
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 05/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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