MAUDE Adverse Event Report: IN2BONES SAS G01 01511; PACK 5 SHANNON BURRS LG20 MM STERILE DIA 2.0 X LENGTH 75 MM

Model Number	G01 01511
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
N/a.
Event or Problem Description
Surgery: hallux valgus.Use of a shannon burr to make the osteotomy ; the burr broke at its extremity into the bone.The surgery duration was increased to remove the piece of broken burr.Another burr was used, the broken burr was kept.
Additional Manufacturer Narrative
The device involved in the event was not returned to the manufacturer.Therefore, no direct evaluation or physical inspection of the product could be performed.The batch record dated 15/05/2019 was reviewed and found compliant, with no deviations reported.Based on the limited information available and in the absence of the returned device, a definitive root cause could not be established.However, considering the nature of the reported fracture at the extremity of the shannon burr during osteotomy, the most probable contributing factor is related to usage conditions, including potential contact with very dense bone during the surgical procedure.No evidence suggests a manufacturing or design defect.
Event or Problem Description
Surgery: hallux valgus.Use of a shannon burr to make the osteotomy ; the burr broke at its extremity into the bone.The surgery duration was increased to remove the piece of broken burr.Another burr was used, the broken burr was kept.

• Brand Name: G01 01511
• 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: 24697830
• Report Number: 3010470577-2020-06091
• Device Sequence Number: 10166987
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: 1904140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown