MAUDE Adverse Event Report: IN2BONES PIT'STOP; PIT'STOP SUBTALAR IMPLANT PEEK SIZE 10MM STERILE

Model Number	M20 SP010
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a subtalar arthrodesis procedure, the surgeon reported difficulty visualizing the pit stop implant under fluoroscopic control.According to the user, the implant did not display the expected radiographic indicators, which are normally visible thanks to the integrated radio-opaque markers.
Additional Manufacturer Narrative
The pitstop is assembled by the supplier simagec.The omission of the radiographic markers occurred during this assembly step.
Event or Problem Description
During a subtalar arthrodesis procedure, the surgeon reported difficulty visualizing the pit stop implant under fluoroscopic control.According to the user, the implant did not display the expected radiographic indicators, which are normally visible thanks to the integrated radio-opaque markers.The provided images show: good visibility of bony structures, the presence of the metal guide used during the procedure, no identifiable radiopaque element corresponding to the expected pit stop markers.The user indicated that insufficient visibility of the device resulted in difficulty locating and assessing the implant's positioning during the procedure.Reference : m20 sp010 batch : 2305095.

• Brand Name: PIT'STOP
• Common Device Name: PIT'STOP SUBTALAR IMPLANT PEEK SIZE 10MM STERILE
• Manufacturer (Section D): IN2BONES; immeuble sequoia; 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: 24207135
• Report Number: 3010470577-2025-12151
• Device Sequence Number: 20207492
• Product Code: HWC
• UDI-Device Identifier: 03760225713334
• UDI-Public: 03760225713334
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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
• Operator of Device: Health Professional
• Device Model Number: M20 SP010
• Device Catalogue Number: M20 SP010
• Device Lot Number: 2305095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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