MAUDE Adverse Event Report: STERIS CORPORATION V. MUELLER; AFFINITY METZENBAUM SCISSORS

Model Number	MA1601
Medical Device Problem Codes	Mechanical Problem (1384); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affinity metzenbaum scissors subject of the reported event were requested to be sent back for evaluation.Investigation of the reported event is currently in progress.A follow-up report will be submitted when additional information becomes available.Udi related data clarification - the lot/serial number is unknown, therefore, the applicable production identifiers were not included in the mdr.
Event or Problem Description
The user facility reported that during a patient procedure their affinity metzenbaum scissors "broke" subsequently causing the screw to fall into the patient.The screw was immediately retrieved.An x-ray was taken as a precaution which confirmed no instrument pieces were present.The procedure was completed successfully.
Additional Manufacturer Narrative
The affinity t/c metzenbaum scissors subject of the reported event were returned for evaluation.Evaluation results determined that a hairline crack was present which may have been a contributing factor of the scissors breaking during use and the screw falling from its housing.The cause of the crack could not be determined.A complaint review was performed and confirmed the event to be isolated for the subject lot.The device history record was reviewed and confirmed the lot was manufactured to specifications; no abnormalities were noted.No additional issues have been reported.

• Brand Name: V. MUELLER
• Common Device Name: AFFINITY METZENBAUM 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: 20624901
• Report Number: 1527821-2024-00018
• Device Sequence Number: 12645897
• Product Code: LRW
• UDI-Device Identifier: 10885403056413
• UDI-Public: (01)10885403056413(10)D21XQS
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2024

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
• Operator of Device: Health Professional
• Device Model Number: MA1601
• Device Catalogue Number: MA1601
• Device Lot Number: (10)D21XQS
• 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: 10/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 03/28/2025
• 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