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

Model Number	89-6112
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation for the reported event is in progress; a follow-up report will be submitted when additional information becomes available.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 during a patient procedure that the metal cable broke off their diamond-flex triangular retractor causing small segments to fall into the patient.The surgeon removed all the pieces, and an x-ray was taken of the patient that confirmed no pieces were present.No report of injury.
Additional Manufacturer Narrative
The device subject of the reported event was returned for evaluation.Evaluation confirmed that the tension cable was severed in two places.The cause of the cable breakage could not be determined.The instructions for use stated, "do not use devices if they do not satisfactorily perform their intended function or have physical damage.".A complaint review was conducted for this lot and confirmed this to be an isolated event.No additional issues have been reported.

• Brand Name: SNOWDEN-PENCER
• Common Device Name: DIAMOND-FLEX TRIANGULAR RETRACTOR
• Manufacturer (Section D): STERIS CORPORATION; 5 sunnen dr; saint louis MO 63143
• Manufacturer (Section G): STERIS CORPORATION; 5 sunnen dr; saint louis MO 63143
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 20516400
• Report Number: 1923569-2024-01014
• Device Sequence Number: 7110521
• Product Code: GCJ
• UDI-Device Identifier: 10885403122835
• UDI-Public: (01)10885403122835(10)L07
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 10/17/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 89-6112
• Device Catalogue Number: 896112
• Device Lot Number: (10)L07
• 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: 09/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 03/26/2025
• 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