MAUDE Adverse Event Report: IN2BONES SAS SCREWDRIVER T8 TORX NON CANNULATED; T8 SCREWDRIVER REUSABLE

Model Number G01 01571

Device Problem Fracture (1260)

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

Event Date 11/08/2023

Event Type  malfunction  

Manufacturer Narrative

Investigations are in-progess.A complete and final mdr-report will be submitted when all investigations are performed.

Event Description

The neofuse ankle fusion plating system is indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia, talus and calcaneus.Removal of the implant is at the discretion of the surgeon, who must consider the risks and benefits when deciding wheter or not to remove the implant.Event description : during the removal of a neofuse plate, the surgeon was unable to unscrew the counterscrews of screws 3.5 and 4.5.The screwdrivers broke, as did the screwdriver from the universal ablation kit.As a result, the plate could not be removed.The decision was taken by the surgeon to leave the plate and associated screws in place, with no patient consequences, as reported by the complaint initiator.

Event Description

The neofuse ankle fusion plating system is indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia, talus and calcaneus.Removal of the implant is at the discretion of the surgeon, who must consider the risks and benefits when deciding whether or not to remove the implant.Event description : during the removal of a neofuse plate, the surgeon was unable to unscrew the counterscrews of screws 3.5 and 4.5.The screwdrivers broke, as did the screwdriver from the universal ablation kit.As a result, the plate could not be removed.The decision was taken by the surgeon to leave the plate and associated screws in place, with no patient consequences, as reported by the complaint initiator.

• Brand Name: SCREWDRIVER T8 TORX NON CANNULATED
• Type of Device: T8 SCREWDRIVER REUSABLE
• Manufacturer (Section D): IN2BONES SAS; 28 chemin du petit bois; bâtiment 2; ecully, 69130 ; ET 69130
• Manufacturer (Section G): IN2BONES SAS; 28 chemin du petit bois; bâtiment 2; ecully, 69130 ; FR 69130
• Manufacturer Contact: sabina ahaddad ; 28 chemin du petit bois; bâtiment 2; ecully, 69130 ; FR 69130
• MDR Report Key: 18281520
• MDR Text Key: 329933403
• Report Number: 3010470577-2023-11111
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K173121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G01 01571
• Device Lot Number: 1812227 AND 2111179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 11/08/2023
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Sex: Male