MAUDE Adverse Event Report: ARTHREX, INC. VAR ANGLE LOCKING SCREW, ¿3.5MM X 10MM; BONE FIXATION SCREW/PLATE

Model Number	VAR ANGLE LOCKING SCREW, ¿3.5MM X 10MM
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screws were mislabeled 8100-xxx but should be 8088-xxx.
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 a manufacturing/packaging issue; however, due to the device not being returned, we are unable to confirm the reported event.As no further investigation was able to be performed no change in harm was identified.

• Brand Name: VAR ANGLE LOCKING SCREW, ¿3.5MM X 10MM
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: 19477858
• Report Number: 1220246-2024-05079
• Device Sequence Number: 17910367
• Product Code: HWC
• UDI-Device Identifier: 00848665025828
• UDI-Public: 00848665025828
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K152732
• 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): 06/06/2024

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: VAR ANGLE LOCKING SCREW, ¿3.5MM X 10MM
• Device Catalogue Number: 8088-010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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