MAUDE Adverse Event Report: IN2BONES SAS DIAM.2,7MM DRILL BIT - AO ATTACHEMENT - NON STERILE - LG 125MM WITH LASER MARKIN; NEOFUSE DRILL

Catalog Number	P02 00281
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The neofuse plating system is a unique plating system for ankle fusion providing a high stability and rigid fixation.The system is composed of an anatomically contoured plate, with a distal part adapted to the talar neck, and a proximal part adapted to the distal tibial epiphysis and diaphysis.The most proximal tibial hole is an oblong hole, which facilitates peroperative handling of the plate by the surgeon as it enables its temporary fixation to the bone.Rigid fixation is achieved by: three 3.5mm diameter surfix type locking screws for talar fixation.Four 4.5mm diameter surfix type locking screws for tibial fixation.An additional 4.5mm interfragmentary screw (transfocal screw) to enhance compression of the tibio-talar joint, up-to the subtalar joint if need be.This cortical screw is inserted in an oblique way to reach the posterior aspect of the talar body, or else the posterior aspect of the calcaneus, should the surgeon wish a complementary subtalar compression.As an adds-on to this plate and screw system, in2bones has developed a targeting device that enables the precise positioning of an i.B.S® 6.5mm screw, applied posteriorly through the tibiotalar joint, to ensure the closure of the posterior hinge and reinforce the stability of the arthrodesis.Event description: when inserting the 2.7 mm drill bit, ancillary to the neofuse plate, into the drill guide at the talus, the drill bit broke due to slight stress, according to dr.(b)(6).This drill bit was removed with rongeurs without any damage.This reportable event is part of a remedition resulting from a 483 letter.
Additional Manufacturer Narrative
Batch record n°1905007 dated 27/jun/2019 is compliant.No non conformity which might explain the complaint was determined.Device manufactured with drawing in force at the time.Ever since then, the part has been lengthened and the quick coupling changed; none of those modifications are related to the issue described here.Few data collected and device wasn't returned.The most likely cause is a use cause by the surgeon.

• Brand Name: DIAM.2,7MM DRILL BIT - AO ATTACHEMENT - NON STERILE - LG 125MM WITH LASER MARKIN
• Common Device Name: NEOFUSE DRILL
• Manufacturer (Section D): IN2BONES SAS; 28 chemin du petit bois; bâtiment 2; ecully, 69130 ; FR 69130
• Manufacturer (Section G): IN2BONES SAS; 28 chemin du petit bois; bâtiment 2; ecully, 69130 ; FR 69130
• Manufacturer Contact: martin geertsema ; 28 chemin du petit bois; bâtiment 2; ecully, 69130 ; FR 69130
• MDR Report Key: 23094935
• Report Number: 3010470577-2021-11031
• Device Sequence Number: 9383387
• Product Code: HTW
• UDI-Device Identifier: 03760225718674
• UDI-Public: 3760225718674
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/19/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: P02 00281
• Device Lot Number: 1905007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male