MAUDE Adverse Event Report: IN2BONES SAS IBS; IBS 2.5-C COMPRESSION SCREW, DIAM2.5 LG 28MM T7

Model Number	S25 ST028
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
N/a.
Event or Problem Description
During the procedure, an ibs 2.5 screw broke at its mid section.The surgeon inserted a guide wire for an ipd arthrodesis and attempted to insert the ibs 2.5 screw with the motor driver.The screw twisted around the guide wire and fractured, resulting in an approximate 25 minute surgical delay.
Additional Manufacturer Narrative
The evaluation was performed using the information contained in the original complaint file and the materials returned at the time of the event.A visual inspection of the returned components was conducted.The 2.5 mm screw exhibited a mid shaft fracture.The proximal portion was found twisted around the guide k-wire, while the k-wire itself remained intact.The fracture surface showed signs consistent with the condition of the product at the time of receipt.According to the information provided, during an ipd arthrodesis procedure the guide k-wire was positioned and the screw was inserted using powered instrumentation.During insertion, the screw began to wrap around the k-wire rather than advance normally, resulting in mechanical overload and subsequent fracture of the screw.The screw was removed and replaced without any reported patient injury.A review of the available production records for lot 1803063 and of-500714-020 confirmed that all specifications were met at the time of release.No deviations or anomalies were recorded in relation to this product.Based on the available information, the event is consistent with mechanical overload during insertion.No corrective or remedial actions have been identified from the documentation available.
Event or Problem Description
During the procedure, an ibs 2.5 screw broke at its mid section.The surgeon inserted a guide wire for an ipd arthrodesis and attempted to insert the ibs 2.5 screw with the motor driver.The screw twisted around the guide wire and fractured, resulting in an approximate 25 minute surgical delay.

• Brand Name: IBS
• Common Device Name: IBS 2.5-C COMPRESSION SCREW, DIAM2.5 LG 28MM T7
• 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: 24647073
• Report Number: 3010470577-2018-12231
• Device Sequence Number: 9918562
• Product Code: HWC
• UDI-Device Identifier: 03760225710173
• UDI-Public: 03760225710173
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K131920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/19/2026

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
• Device Model Number: S25 ST028
• Device Catalogue Number: S25 ST028
• Device Lot Number: 1803063
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (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: Female