MAUDE Adverse Event Report: IN2BONES SAS I.B.S SCREW; TORX T15 REUSABLE SCREWDRIVERS

Model Number G01 00331 & G01 00361

Device Problem Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2020

Event Type  malfunction  

Manufacturer Narrative

Batch records (in2bones batch number 1705026 and 1507100) were reviewed and found to be compliant.Visual inspection done on the instruments pictures sent by the complaint initiator: both screwdrivers tip is twisted.No broken part visible.One screwdriver seems to have been twisted while implanting a screw and the second one appears to have been damaged while removing a screw.The return of the involved instruments at in2bones has been requested for additional analysis.This is the first reported occurrence of a screwdriver damaged during surgery leading to a significant increase of the surgery duration.A global review of all the reported cases of t15 reusable screwdrivers failures showed that this defect is associated to a failure rate of 0.14% and a severity quoted as "minor"; which are deemed acceptable as per in2bones internal health risk index evaluation (sop par04).Calculation details: number of involved t15 reusable twisted and / or broken screwdrivers involved in complaints / number of screws implanted thanks to t15 reusable screwdrivers.

Event Description

The i.B.S compression and neutralization osteosynthesis screws are intended for: the fixation of arthrodesis, osteotomies or fractures of long or short bones of the upper and lower limbs; osteosynthesis requiring a mono or bicortical compression.The 4.5mm diameter screws are to be implanted thanks to t15 reusable screwdrivers.Event description: during a patella surgery, the tip of two reusable t15 screwdrivers twisted, leading the surgeon to use more strength than usual to implant the screws.The surgery ended successfully without any consequences for the patient.This event is reportable, since the distributor estimated that it induced a significant increase in the surgery duration (estimated to be of more than 30 minutes but less than one hour).

• Brand Name: I.B.S SCREW
• Type of Device: TORX T15 REUSABLE SCREWDRIVERS
• Manufacturer (Section D): IN2BONES SAS; 28 chemin du petit bois; batiment 2; ecully, 69130 ; FR 69130
• Manufacturer (Section G): IN2BONES SAS; 28 chemin du petit bois; batiment 2; ecully, 69130 ; FR 69130
• Manufacturer Contact: morgane grenier ; 28 chemin du petit bois; batiment 2; ecully, 69130 ; FR 69130
• MDR Report Key: 10827498
• MDR Text Key: 252287386
• Report Number: 3010470577-2020-02091
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K131920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2020

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 Model Number: G01 00331 & G01 00361
• Device Lot Number: 1507100 & 1705026
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 11/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2015
• 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
• Patient Age: 16 YR