MAUDE Adverse Event Report: IN2BONES SAS REUSABLE DRILL; DRILL DIAM 3.0 - A.O - LG 110MM, NON STERILE CANNULATED 1.6MM

Model Number G01 00091

Device Problem Material Twisted/Bent (2981)

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

Event Date 02/13/2020

Event Type  malfunction  

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 implantation of 4.5mm diameter screws is to be prepared thanks to a g01 00091 drill (associated to a 1.6mm k-wire).Event description: during an osteosynthesis / reconstruction surgery, it was reported that when the surgeon tried to prepare the screw pathway, the drill twisted.The surgeon had to make strength to remove the instrument.The surgery ended successfully without any consequences for the patient.This event is reportable since if it were to happen again, it could cause a serious injury to the patient.Additional information: the return of the involved instruments at in2bones has been requested for further analysis, but have not yet been done (in2bones internal and distributor organization difficulties during the covid-19 crisis).However, a picture of the damaged instruments has been received: a k-wire appears to be stuck inside the drill, and both instruments are twisted near their distal extremity.

• Brand Name: REUSABLE DRILL
• Type of Device: DRILL DIAM 3.0 - A.O - LG 110MM, NON STERILE CANNULATED 1.6MM
• 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: 10827776
• MDR Text Key: 247452406
• Report Number: 3010470577-2020-02331
• Device Sequence Number: 1
• Product Code: HTW
• 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: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G01 00091
• Device Lot Number: 1502050
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• 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