MAUDE Adverse Event Report: IN2BONES SAS TORX T8 ATTACHMENT SCREWDRIVER

Catalog Number G01 00261

Device Problem Material Disintegration (1177)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 08/06/2019

Event Type  malfunction  

Manufacturer Narrative

Risk assessment was conducted thanks to both the raw material composition of the screwdriver and literature analysis of toxicological effects of its various compounds (si, mn, ni, cr,s, p, c), using a worst-case approach for the calculation of the size of the implanted piece (thickness and surface maximized compared to real part) and the size of the human body in which it was implanted (assessment based on a 50kg patient, i.E.A small stature person).It was concluded that the implanted piece has a very low risk of corrosion (passivated layer).And even if it were to be fully corroded, the piece is not likely to induce any toxicological reaction due to the low quantity of compounds hypothetically released into the body (safety ratios between 9 and 95000 depending upon the compounds).In addition, the risk of migration of the piece of screwdriver is judged remote, since it is stuck in the implantable osteosynthesis screw head, with tight tolerances.This was the first occurrence of this device breakage recorded into in2bones (b)(4).Such events will continue to be monitored in the future.

Event Description

Orthopaedic foot surgery.The surgeon was performing a lapidus procedure on the foot using colink osteosynthesis screws (manufactured by in2bones usa).After the surgery completion, the surgeon took x-rays.Upon viewing the x-rays, the surgeon felt the screws implanted were too long and decided to remove two screws and replace them with shorter screws.The first screw was removed using the in2bones sas torx t8 attachment screwdriver with no issue.When the surgeon went to remove the second screw (a 3.0x20mm colink locking screw), the tip of the screwdriver broke off into the screw head.The surgeon was unable to remove the broken tip of the screwdriver from the screw head.The broken tip of the screwdriver and the screw remained in the patient.The surgeon was able to successfully complete the procedure nonetheless.Patient outcome: the patient was implanted with a small instrument part (screwdriver tip) not meant to be implanted.The implanted part is located into an osteosynthesis screw head, and locked into it with a limited risk of migration.No other clinical consequences reported, as the surgeon was able to successfully complete the procedure.

• Brand Name: TORX T8 ATTACHMENT SCREWDRIVER
• Type of Device: TORX T8 ATTACHMENT SCREWDRIVER
• Manufacturer (Section D): IN2BONES SAS; 28 chemin du petit bois; lyon, 69130 ; FR 69130
• Manufacturer (Section G): IN2BONES SAS; 28 chemin du petit bois; lyon, 69130 ; FR 69130
• Manufacturer Contact: morgane grenier ; 28 chemin du petit bois; lyon, 69130 ; FR 69130
• MDR Report Key: 9154948
• MDR Text Key: 219215652
• Report Number: 3010470577-2019-09181
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/03/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: G01 00261
• Device Lot Number: 1810064/1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 10/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1