MAUDE Adverse Event Report: ARTHREX, INC. 2.4 X 18MM VAL SCREW, TI; BONE FIXATION PLATE

Model Number 2.4 X 18MM VAL SCREW, TI

Device Problem Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2024

Event Type  malfunction  

Event Description

On 02/23/2024, it was reported by a sales representative via phone that an ar-8724v-20 low profile va locking screw went through the plate, and (3) ar-8724v-18 low profile va locking screws would not lock into the plate.This occurred during a distal radius procedure on (b)(6) 2024, where the plate was still used in the case however, a screw was not placed in the area where the ar-8724v-20 went through.The case was completed using screws from a mini frag set.There was no harm to the patient.

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: 2.4 X 18MM VAL SCREW, TI
• Type of Device: 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: 18859860
• MDR Text Key: 337157220
• Report Number: 1220246-2024-01364
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867045613
• UDI-Public: 00888867045613
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131474
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2.4 X 18MM VAL SCREW, TI
• Device Catalogue Number: AR-8724V-18
• Device Lot Number: 14951394
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1