MAUDE Adverse Event Report: STERIS CORPORATION SNOWDEN-PENCER; SNOWDEN-PENCER MIS 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	12/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via user facility medwatch report (mw5163614) that during a patient procedure their snowden-pencer mis diamond-flex triangular retractor broke, and metal pieces fell into the patient.All pieces were successfully retrieved; this was confirmed via x-ray.No report of injury.
Additional Manufacturer Narrative
The reported medwatch mw5163614 did not provide a user facility name, address, phone number or email contact.Without the user facility's contact information, steris is unable to obtain additional information regarding the reported event.The snowden-pencer mis diamond-flex triangular retractor of the reported event is unavailable for evaluation due to the user facility not being able to be contacted.Without the return or inspection of the subject device, a root cause cannot be determined.A follow-up report will be submitted should additional information become available.No additional issues have been reported.Udi related data clarification - the lot/serial number is unknown, therefore, the applicable production identifiers were not included in the mdr.

• Brand Name: SNOWDEN-PENCER
• Common Device Name: SNOWDEN-PENCER MIS DIAMOND-FLEX TRIANGULAR 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: 21285339
• Report Number: 1923569-2025-00002
• Device Sequence Number: 18133010
• Product Code: GCJ
• UDI-Device Identifier: 10885403122835
• UDI-Public: (01)10885403122835
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 01/31/2025

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: 89-6112
• Device Catalogue Number: 896112
• 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: 01/06/2025
• Initial Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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