MAUDE Adverse Event Report: ARTHREX, INC. VAL KREULOCK SCREW, TI, 3.0X18; BONE FIXATION PLATE

Model Number VAL KREULOCK SCREW, TI, 3.0X18

Device Problem Failure to Advance (2524)

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

Event Date 06/20/2023

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.

Event Description

On 06/14/2023, it was reported by a sales representative via phone that an ar-8933vcl-18 kreulock screw would not thread in the plate, it would just spin.This occurred during the first mtp fusion on (b)(6) 2023, a hole was drilled and when they tried to insert the screw it would not thread it was just spinning.The screw was removed, and the case was completed using another screw.There was no effect on the patient.

• Brand Name: VAL KREULOCK SCREW, TI, 3.0X18
• 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: emily shafer ; 8009337001
• MDR Report Key: 17364128
• MDR Text Key: 319795654
• Report Number: 1220246-2023-07242
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867324190
• UDI-Public: 00888867324190
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201132
• 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: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VAL KREULOCK SCREW, TI, 3.0X18
• Device Catalogue Number: AR-8933VCL-18
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/22/2023
• 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