MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO LOCK SCRW,TI,3.5MMX 10MM, STRL; BONE FIXATION PLATE

Model Number	LO-PRO LOCK SCRW,TI,3.5MMX 10MM, STRL
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ar-8935l-10s the screw is not locking into the hole.No adverse effect on the patient.
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 allegation is not confirmed.One unpackaged ar-8935l-10s was received for investigation.Visual evaluation did not identify any damage or malfunction.Functional testing found no problem with the device.

• Brand Name: LO-PRO LOCK SCRW,TI,3.5MMX 10MM, STRL
• Common Device Name: BONE FIXATION 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: 19575324
• Report Number: 1220246-2024-06282
• Device Sequence Number: 8493534
• Product Code: HRS
• UDI-Device Identifier: 00888867210868
• UDI-Public: 00888867210868
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/20/2024

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: 11/30/2024
• Device Model Number: LO-PRO LOCK SCRW,TI,3.5MMX 10MM, STRL
• Device Catalogue Number: AR-8935L-10S
• Device Lot Number: 10500855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2019
• 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