MAUDE Adverse Event Report: IN2BONES SAS OS2®-VP; OS2-VP VARISATION STAPLE KIT INTERAXIS 9 MM 90°

Model Number	T40 SP190
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2016
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the staple broke while being released from the inserter, before implantation.The surgeon drilled a new hole and used a second staple to complete the procedure.No patient injury was reported.The broken staple was returned for evaluation, and the distributor confirmed that the event involved a product malfunction.
Additional Manufacturer Narrative
Information was received indicating that a staple from the os2 vp system (lot 1605004) broke during implantation on (b)(6) 2016.According to the healthcare professional, the staple appeared to fracture when being released from the inserter.The broken staple was removed and replaced during the procedure.No patient injury was reported.The device involved in the event was returned in 2016 and visually examined at that time.A fracture was observed on one leg near the bridge area.No material abnormalities or non conformities were identified during the original evaluation.The appearance of the fracture was consistent with mechanical overload during use.This case dates back to 2016.No additional testing can therefore be performed.Based on the information available from the initial evaluation, no manufacturing related cause could be confirmed and the event is considered isolated.
Event or Problem Description
During a surgical procedure on (b)(6) 2016, one staple from the os2-vp implant system (lot 1605004) broke during implantation.According to the healthcare professional, the staple appeared to break when being released from the inserter.The broken staple was removed and replaced with a new staple.No patient injury was reported.The product was returned on october 10, 2016 for evaluation.Visual inspection confirmed a fracture on one leg near the bridge area.No manufacturing defect or material abnormality was identified.The fracture characteristics were consistent with mechanical overload during use.

• Brand Name: OS2®-VP
• Common Device Name: OS2-VP VARISATION STAPLE KIT INTERAXIS 9 MM 90°
• Manufacturer (Section D): IN2BONES SAS; immeuble sequoia 3; 97 allée alexandre borodine; saint-priest, 69800 ; FR 69800
• Manufacturer (Section G): IN2BONES; 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: 24637031
• Report Number: 3010470577-2016-10061
• Device Sequence Number: 9918659
• Product Code: JDR
• UDI-Device Identifier: 03760225715154
• UDI-Public: 03760225715154
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153770
• 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
• Remedial Action: 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: T40 SP190
• Device Catalogue Number: T40 SP190
• Device Lot Number: 1605004
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2016
• Supplement Date Received by Manufacturer: 10/06/2016
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 03/19/2026
• 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
• Patient Sex: Unknown