MAUDE Adverse Event Report: IN2BONES SAS QUANTUM®; QUANTUM® RESECTION GUIDE FOR TALAR CHAMFER S3

Catalog Number	M05 01001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch record 1906214/1 was reviewed and found to be compliant: (b)(4) products were released on january 14th, 2021.The products were machined by phen'x as per (b)(4).1 quality file reported on this batch, that could not have caused the issue reported: (b)(4): concessions regarding first batches manufacturing of the quantum reusable instruments.At the date on june 15th, 2023: no other complaints reported on this batch.The product was returned: the defect is confirmed, the instrument has a broken pin.The instrument was manufactured as per drawings and specifications in force at that time: - m05 01001 : m05 016 rev b + m05 066 rev b.No concern raised on this reference as per pms meeting performed on december 08th, 2022.The root cause determined is a wrong use by the surgeon (cf event description).
Event or Problem Description
The quantum® total ankle prosthesis is indicated as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.The quantum® total ankle prosthesis is a fixed-bearing, semi-constraint ankle prothesis with 2 components and composed of: - a tibial component composed of a metallic (ta6v) tibial tray implant fixed to a polymer (uhwmpe) insert, - a metallic (cocr) talar implant reproducing the talus dome anatomy.When all components are implanted, with the insert rigidly locked to the tibial tray, the polyethylene insert acts as a single bearing along the talar dome, enabling flexion/extension and rotation movement at the replaced ankle joint.Each component of the quantum® total ankle prosthesis exists in different sizes and models.Event description: talar chamfer resection guides (intra-operatively) it was reported by the sales rep, during the placement of the talar chamfer resection guides into hard bone, dr.(b)(6) applied pressure to get the instrument in the desired orientation, levering the instrument to adjust the plane.During the placement of the instrument one of the trocar tips located on the bottom of the instrument broke off.The surgeon was able to remove the broken piece from the bone, by placing a k-wire (same size as the broken piece) into the hole and proceeding with reaming for the lug.The broken piece came out with the lug reamer.Note: the surgeon may have forced the instrument into an orientation outside of the intended use.There was no significant impact to the patient or surgery time.The product was returned to in2 bones, usa and will be shipped to you for evaluation.A tracking number will be provided, when shipped.This reportable event is part of a remedition resulting from a 483 letter.

• Brand Name: QUANTUM®
• Common Device Name: QUANTUM® RESECTION GUIDE FOR TALAR CHAMFER S3
• Manufacturer (Section D): IN2BONES SAS; 28 chemin du petit bois; bâtiment 2; ecully, 69130 ; FR 69130
• Manufacturer (Section G): IN2BONES SAS; 28 chemin du petit bois; bâtiment 2; ecully, 69130 ; FR 69130
• Manufacturer Contact: martin geertsema ; 28 chemin du petit bois; bâtiment 2; ecully, 69130 ; FR 69130
• MDR Report Key: 23096472
• Report Number: 3010470577-2022-08121
• Device Sequence Number: 8731096
• Product Code: FZX
• UDI-Device Identifier: 03701337601126
• UDI-Public: 3701337601126
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/19/2025

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 Catalogue Number: M05 01001
• Device Lot Number: 1906214/1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male