MAUDE Adverse Event Report: INCIPIO DEVICES SA OFFSET CUP IMPACTOR - M8X1 INTERFACE

Model Number	01.15.10.0556
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Photographs provided with the event report confirm the product failure.The strike plate has fractured at the alignment guide groove.The reported issue has been identified as an anticipated end of life failure in the product risk management file.The risks associated with the strike plate fracture have been reduced as a far as possible and residual risk is low and acceptable.Occurrence levels remain acceptable.The failure will continue to be tracked as part of routine trend monitoring activities.The cause of the issue is fatigue following many years of use and reuse.No corrective action is considered necessary at this time.
Event or Problem Description
The back part of the impactor broke while the cup was being impacted.Since the impaction was almost complete, no backup instruments were used and the surgery was completed successfully.Event occured in japan.Product is also marketed in the us.

• Brand Name: OFFSET CUP IMPACTOR - M8X1 INTERFACE
• Common Device Name: OFFSET CUP IMPACTOR
• Manufacturer (Section D): INCIPIO DEVICES SA; avenue des paquiers 16; st. blaise, neuchatel 2072 ; SZ 2072
• MDR Report Key: 22307005
• Report Number: 3013223655-2025-00001
• Device Sequence Number: 7934652
• Product Code: HWA
• UDI-Device Identifier: 07630055302458
• UDI-Public: 07630055302458
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2025

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
• Operator of Device: Health Professional
• Device Model Number: 01.15.10.0556
• Device Catalogue Number: 01.15.10.0556
• Device Lot Number: 20J10444
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2020
• 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 Sex: Unknown