MAUDE Adverse Event Report: IN2BONES SAS SHANNON BURRS STERILE; SHANNON BURRS STERILE DEVICE

Model Number	G01 01511
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Itv date: (b)(6)2025.Surgeon: dr.(b)(6).Patient: male, 22 years old.Incriminated devices available for analysis: shannon burrs lg 20mm, diam 2.0mm x length 75mm; ref (b)(4); batch 2502104.Incident: use of four shannon burrs, which broke instantly upon use, leaving the tip in the bone.A decision was made to use another, smaller model, length 12.Consequence: increased surgical time and tourniquet time.(15 - 30 minutes).The surgeon confirmed after discussion that he was able to remove the fragments.

• Brand Name: SHANNON BURRS STERILE
• Common Device Name: SHANNON BURRS STERILE DEVICE
• Manufacturer (Section D): IN2BONES SAS; immeuble sequoia 3; 97 allée alexandre borodine; saint priest, lyon 69800 ; FR 69800
• Manufacturer (Section G): IN2BONES SAS; immeuble sequoia 3; 97 allée alexandre borodine; saint priest, lyon 69800 ; FR 69800
• Manufacturer Contact: martin geertsema ; immeuble sequoia 3; 97 allée alexandre borodine; saint priest, lyon 69800 ; FR 69800
• MDR Report Key: 24244643
• Report Number: 3010470577-2025-08291
• Device Sequence Number: 21237066
• Product Code: GFF
• UDI-Device Identifier: 03760225715901
• UDI-Public: (01)03760225715901(17)300228(10)2502104
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K191380
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 11/17/2025

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?: No
• Device Model Number: G01 01511
• Device Catalogue Number: G01 01511
• Device Lot Number: 2502104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 02/03/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 22 YR
• Patient Sex: Male