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

Model Number	G01 01512
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The drill bit broke during the procedure.The fragment was removed, and a minor injury occurred to the user.Both parties are doing well.
Additional Manufacturer Narrative
Following our internal investigation, it was confirmed that the burr used during the chiectomy (removal of excess bone) was not the correct one: a shannon burr was used, whereas the most appropriate model for this procedure is a wedge burr.The problem is related to a usage error and not to the product design., following our internal investigation, it was confirmed that the burr used during the chiectomy (removal of excess bone) was not the correct one: a shannon burr was used, whereas the most appropriate model for this procedure is a wedge burr.The problem is related to a usage error and not to the product design.
Event or Problem Description
The drill bit broke during the procedure.The fragment was removed, and a minor injury occurred to the user.Both parties are doing well.

• Brand Name: SHANNON BURR
• Common Device Name: SHANNON BURR 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: 24602892
• Report Number: 3010470577-2026-02081
• Device Sequence Number: 8569114
• Product Code: GFF
• UDI-Device Identifier: 03760225715918
• UDI-Public: 03760225715918
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: G01 01512
• Device Catalogue Number: G01 01512
• Device Lot Number: 2404193
• 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: 02/17/2026
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/27/2026
• 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