MAUDE Adverse Event Report: STERIS CORPORATION V.MUELLER; STERNAL BLADE

Model Number	CH1290
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The titanium ankeney sternal blade is being returned to steris for evaluation.Investigation of this event is in process.A follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during a heart procedure the titanium ankeney sternal blade broke in half.The procedure was completed successfully with a different instrument.No report of injury or procedure delay.
Additional Manufacturer Narrative
The device was returned to the supplier for evaluation.The supplier confirmed the titanium ankeney sternal retractor was broken into two pieces and the most likely root cause is user facility misuse (rough handling or overstressing).The device history record for the subject lot was reviewed and confirmed the device was manufactured to specifications; no abnormalities were noted.The instructions for use for the titanium ankeney sternal retractor states, "use of a device for a task other than what it is intended for will usually result in a damaged or broken device.Prior to use, inspect devices to ensure proper function and condition.Do not use devices if they do not satisfactorily perform their intended function or if they have physical damage.Avoid mechanical shock or overstressing the devices." the steris territory manager offered in-service training on the proper use and operation of the retractor; however, the user facility declined.No additional issues have been reported.

• Brand Name: V.MUELLER
• Common Device Name: STERNAL BLADE
• Manufacturer (Section D): STERIS CORPORATION; 5960 heisley rd; mentor OH 44060
• Manufacturer (Section G): STERIS CORPORATION; 5960 heisley rd.; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 20137734
• Report Number: 1527821-2024-00010
• Device Sequence Number: 12633011
• Product Code: DWS
• UDI-Device Identifier: 10885403023705
• UDI-Public: (01)10885403023705(10)C24VIN
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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: CH1290
• Device Catalogue Number: CH1290
• Device Lot Number: (10)C24VIN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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