MAUDE Adverse Event Report: IN2BONES SAS I.B.S®-C COMPRESSION SCREWS; I.B.S® 2.5-C COMPRESSION SCREW - DIAMETER 2.5MM LENGTH 22MM

Catalog Number	S25 ST022
Medical Device Problem Codes	Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fall (1848)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch record was assessed and as per contents no nc occurred during the manufacturing process.No nc is identified which might explain the complaint.Patient accident, out of scope of reasonably foreseeable misuse.
Event or Problem Description
Device description: the i.B.S®-c compression osteosynthesis screws are intended for the fixation of arthrodesis, osteotomies or fractures of long or short bones of the upper and lower limbs.The size of the chosen screw should be adapted to the specific indications.Event description: on (b)(6) 2024, conmed customer service received an email from a patient reporting a serious incident involving an implanted orthopedic screw.The patient underwent surgery in (b)(6) 2023 during which six ibs 2.5-c compression screws (diameter 2.5 mm, length 22 mm, t7) were implanted in the toes.On (b)(6) 2024, the patient experienced an event while getting into bed, during which the middle toe became caught in a rug.This resulted in the bending of one of the implanted screws and a damage of the toe.The patient underwent a revision surgery to remove the bent screw and replace it with alternative hardware.The email included a photo of the affected toe and the bent screw.Note: this reportable event is part of a remedition resulting from a 483 letter.

• Brand Name: I.B.S®-C COMPRESSION SCREWS
• Common Device Name: I.B.S® 2.5-C COMPRESSION SCREW - DIAMETER 2.5MM LENGTH 22MM
• 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: 23096700
• Report Number: 3010470577-2024-08041
• Device Sequence Number: 15636123
• Product Code: HWC
• UDI-Device Identifier: 03760225710142
• UDI-Public: 3760225710142
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: S25 ST022
• Device Lot Number: 2304342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• 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): 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female