MAUDE Adverse Event Report: STERIS CORPORATION SNOWDEN-PENCER; DIAMOND-FLEXTRIANGULAR RETRACTOR

Model Number	89-6110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the 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 their diamond-flextriangular retractor "broke" during a patient procedure.
Additional Manufacturer Narrative
Steris made multiple attempts to contact the user facility to obtain additional information regarding the reported event however, the user facility has not responded.The diamond-flextriangular retractor was requested back for evaluation however, to date, the device has not been returned.Without the return or evaluation of the device, the cause of the reported event cannot be determined.The instructions for use states, "1)prior to use, inspect device to ensure proper function and condition.Do not use devices if they do not satisfactorily perform their intended function or have physical damage and 2) inspect devices before each use for broken, cracked, tarnished surfaces, movement of hinges, and chipped or worn parts.If any of these conditions appear, do not use the device.Return device to authorized repair service center for repair or replacement." user facility personnel were counseled on the importance of properly inspecting the device prior to use.No additional issues have been reported.

• Brand Name: SNOWDEN-PENCER
• Common Device Name: DIAMOND-FLEXTRIANGULAR RETRACTOR
• Manufacturer (Section D): STERIS CORPORATION; 5 sunnen drive; maplewood MO 63143
• Manufacturer (Section G): STERIS CORPORATION; 5 sunnen drive; maplewood MO 63143
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4402597401
• MDR Report Key: 22333463
• Report Number: 1923569-2025-00008
• Device Sequence Number: 8994318
• Product Code: GCJ
• UDI-Device Identifier: 10885403122811
• UDI-Public: (01)10885403122811
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K092684
• 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): 06/25/2025

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
• Operator of Device: Health Professional
• Device Model Number: 89-6110
• Device Catalogue Number: 896110
• Device Lot Number: NC
• 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: 05/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/1988
• 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