MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO LOCK SCRW,SS 2.7X 14MM; BONE FIXATION SCREW/PLATE

Model Number	LO-PRO LOCK SCRW,SS 2.7X 14MM
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 1/13/2023 it was reported by a sales representative via phone that qty.2 of an ar-8827l-14 lo-pro lock screw had an issue.During an ankle fracture procedure on (b)(6) 2023, when the surgeon was trying to lock the screws into the plate, they kept spinning.Both screws were removed in one piece, and nothing broke inside the patient.The surgeon used the baseplate, made two holes next to the original holes, and used two non-locking screws ar-8827-14 lo-pro screws with unknown lot numbers instead.The case was completed successfully with no harm to the patient.The complaint devices were discarded and no pictures were taken.
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 misuse/mishandling due to damage to the device.

• Brand Name: LO-PRO LOCK SCRW,SS 2.7X 14MM
• 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: 19478110
• Report Number: 1220246-2024-05092
• Device Sequence Number: 17161595
• Product Code: HWC
• UDI-Device Identifier: 00888867047051
• UDI-Public: 00888867047051
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• 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: LO-PRO LOCK SCRW,SS 2.7X 14MM
• Device Catalogue Number: AR-8827L-14
• Device Lot Number: 14696485
• 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
• Date Device Manufactured: 12/08/2021
• 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