MAUDE Adverse Event Report: IN2BONES SAS IN2BONES; PACK 5 SHANNON BURRS LG20 MM STERILE DIA 2.0 X LENGTH 75 MM

Model Number	G01 01511
Medical Device Problem Codes	Product Quality Problem (1506); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
3 burrs with the same batch record broke.2 broke in patients' metatarsals; 1 broke when taken out of the packaging.
Additional Manufacturer Narrative
N/a.
Additional Manufacturer Narrative
The returned burr and an unopened unit were visually inspected and measured.A dimensional variability of the inner diameter under the cutting blades was identified.This characteristic results from the manufacturing method and was not previously included in routine inspections.Although this variation may reduce the mechanical margin of safety in certain loading conditions, no evidence of a systemic or critical manufacturing defect was found.Information provided by the healthcare facility indicates that two events occurred under conditions that increased mechanical stress on the device, including off indication use and excessive force applied at the distal tip.These factors contributed to creating a lever effect at the cutting end, consistent with the observed fracture pattern.Based on the investigation, the event is linked to a combination of factors, including dimensional variability inherent to the manufacturing process and use conditions that exceeded the expected mechanical load.No corrective action on distributed products was required.Recommendations were implemented to enhance dimensional monitoring during future production.
Event or Problem Description
3 burrs with the same batch record broke.2 broke in patients' metatarsals; 1 broke when taken out of the packaging.

• Brand Name: IN2BONES
• Common Device Name: PACK 5 SHANNON BURRS LG20 MM STERILE DIA 2.0 X LENGTH 75 MM
• Manufacturer (Section D): IN2BONES SAS; immeuble sequoia 3; 97 allée alexandre borodine; saint-priest, 69800 ; FR 69800
• Manufacturer (Section G): IN2BONES SAS; immeuble sequoia 3; 97 allée alexandre borodine; saint-priest, 69800 ; FR 69800
• Manufacturer Contact: benjamin krempel ; immeuble sequoia 3; 97 allée alexandre borodine; saint-priest, 69800 ; FR 69800
• MDR Report Key: 24711249
• Report Number: 3010470577-2020-09151
• Device Sequence Number: 14887961
• Product Code: GFF
• UDI-Device Identifier: 03760225715901
• UDI-Public: 03760225715901
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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 Model Number: G01 01511
• Device Catalogue Number: G01 01511
• Device Lot Number: 2007066
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown