MAUDE Adverse Event Report: NOVASTEP SAS ARCAD® 2.0; COMPRESSIVE STAPLE QUADRO 30X16X16X14X12

Model Number	CSK301612
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
We were informed on the (b)(6) 2025.That 4 broken compressive staple quadro 30x16x16x14x12, with no accompanying investigations or further case information.No batch numbers were available, as the products had been discarded, no dates have been communicated or further information about these cases.It seems like one or more revision surgeries were performed this was not confirmed and we are unable to have further information regarding these surgeries.
Additional Manufacturer Narrative
The surgeon recommended a four-week period of non-weight bearing, which is considered an aggressive duration.Further investigation is not possible due to a lack of additional information regarding this case.

• Brand Name: ARCAD® 2.0
• Common Device Name: COMPRESSIVE STAPLE QUADRO 30X16X16X14X12
• Manufacturer (Section D): NOVASTEP SAS; 2 all jacques frimot; rennes, 35000 ; FR 35000
• Manufacturer Contact: patrick lebas ; 2 all jacques frimot,; rennes, 35000 ; FR 35000
• MDR Report Key: 23932642
• Report Number: 3010673777-2025-00044
• Device Sequence Number: 9527813
• Product Code: JDR
• UDI-Device Identifier: 03700879516554
• UDI-Public: 03700879516554
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K230724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/31/2025

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 Model Number: CSK301612
• Device Lot Number: NOT COMMUNICATED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown