MAUDE Adverse Event Report: STERIS CORPORATION V. MUELLER; SUTURE CARRYING SCISSORS

Model Number	RH1634
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The littler suture carrying scissors will be returned to steris for further evaluation.The investigation is currently 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 patient procedure the screws fell out of multiple littler suture carrying scissors.The screws did not contact the patient and were successfully retrieved by user facility personnel.The procedure was completed successfully with a different instrument.No report of injury.
Additional Manufacturer Narrative
The h10 related reported number was included in the initial mdr in error.There is no related report number associated with mdr # at this time.
Additional Manufacturer Narrative
The device was returned to the supplier for investigation.The supplier confirmed the screws were loose and attributed the screws being mechanically loosened.The device history record for the subject lot was reviewed and confirmed the device was manufactured to specifications; no abnormalities were noted.The ifu for the littler suture carrying scissors 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.Avoid mechanical shock or overstressing the devices.Do not use devices if they do not satisfactorily perform their intended function or if they have physical damage.Only the cleaning and sterilization processes which are defined within these instructions for use have been validated." a steris account manager provided in-service training regarding the proper use and operation of the littler suture carrying scissors.No additional issues have been reported.

• Brand Name: V. MUELLER
• Common Device Name: SUTURE CARRYING SCISSORS
• 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: 20108336
• Report Number: 1527821-2024-00009
• Device Sequence Number: 7869531
• Product Code: KBD
• UDI-Device Identifier: 10885403113222
• UDI-Public: (01)10885403113222(10)K23XTA
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 08/30/2024

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: RH1634
• Device Catalogue Number: RH1634
• Device Lot Number: (10)K23XTA
• 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: 07/31/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/30/2024
• Supplement Report FDA Received Date: 10/08/2024; 10/17/2024
• 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