MAUDE Adverse Event Report: IN2BONES SAS DRILL DIAM 3.0 - AO - LG110MM NON STERILE CANULATED 1.6MM

Catalog Number	G01 00091
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Refer to f.Fogarotto (from the distributor company in italia) email dated on (b)(6) 2021: « we have a problem with 1.6mm drill ref.(b)(4).In the last period these drills break at each surgery.I though it was the surgeon's mistake, but when i told them to be careful, to follow the surgical technique and possibly give me feedback, the drill broke again.The drills broke in the opened part.I don't know if the problem lies in the design but i think you should go deeper in that.» additional information received by e-mail on november 17th, 2021: « - yes, the surgeries were completed without any problems.- no, there were no particular conditions.2 different surgeon, 4 different patients, different ages, different indications, different implant site.- we got another broken drill just yesterday.Here the batch numbers: 1809019, 1706211 (x2), 2101108.» "the broken drills are new, no signs of wear.".
Additional Manufacturer Narrative
Batch record 1809019 and of-18070274-f1 were reviewed and found to be compliant.105 products were released on february 21st, 2019.The devices have a low hrc but its value is within the acceptable range.Batch record 2101108 and of-21010075 were reviewed and found to be compliant.56 products were released on march 17th, 2021.The devices have a low hrc but its value is within the acceptable range.Batch record 1706211 and of-17080153 were reviewed and found to be compliant.125 products were released on september 29th, 2017.Products not returned.The defect is visually confirmed through the pictures provided by the complaint initiator.For the 4 involved instruments, the breakage happened near the window of the instrument.Drill g01 00091 is intended to be used for the implantation of diameter 4.5mm ibs c/n screws.The instruments were manufactured according to drawing in force at time (g01 009 rev 04 and 05).At the date of the event, this drawing is at its revision 06.The changes implemented between those revisions could not have prevented the event reported in this complaint:.Update from revision 04 to 05 is related to the marking of the ao part.Update from revision 05 to 06 is related to the addition of a raw material standard reference keeping the astm f899.It is to be noted that, as described in ibs cn pms meeting reports rev 04 and 05, several complaints have been reported on k-wires that slid-out of the drill through the window during surgery (cannulated drills for mid hind foot surgeries); leading to the opening of a design change (dm2101-13).The aim of this change is to assess the possibility to remove the window form those drills design (the window exists in the drills' design for raw material supply reasons and for steam sterilization).The event reported in this complaint seems to be related to wear from use and is not related to the instrument design.However, the removal of the window from the instrument, managed as per dm2101-13, might prevent new occurrences of this type of incident.

• Brand Name: DRILL DIAM 3.0 - AO - LG110MM NON STERILE CANULATED 1.6MM
• Common Device Name: 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: 23095811
• Report Number: 3010470577-2021-11171
• Device Sequence Number: 12953353
• Product Code: HTW
• UDI-Device Identifier: 03760225713105
• UDI-Public: 3760225713105
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Biomedical Engineer
• 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: G01 00091
• Device Lot Number: 1809019; 1706211 ; 2101108
• 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: 11/12/2021
• 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 Sex: Unknown