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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris is pending the return of the devices subject of the reported event for evaluation.A follow-up report will be submitted once 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 patient procedures two of their snowden-pencer mis diamond-flextriangular retractors "broke" resulting in procedure delays.No report of injury.
Additional Manufacturer Narrative
The devices subject of the reported event were returned to steris for evaluation.Upon evaluation, it was discovered that the tension cables to both devices were broken.The cause of the broken tension cables was attributed to user facility personnel not using the sterilization sleeve of the grasper.The snowden-pencer mis diamond-flex triangular retractor ifu states, "when sterilizing or storing the device, always use protective sterilizing sleeve provided.Failure to use the sleeve may result in premature device failure.This device should never be folded or bent to fit into a small sterilization tray." a steris account manager provided in-service training on the proper use and operation of the retractor.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 road; mentor, OH 44060
• MDR Report Key: 21766117
• Report Number: 1923569-2025-00004
• Device Sequence Number: 18265414
• Product Code: GCJ
• UDI-Device Identifier: 10885403122811
• UDI-Public: 10885403122811
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/03/2025

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
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 07/28/2025
• 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