MAUDE Adverse Event Report: STERIS DEUTSCHLAND GMBH SNOWDEN-PENCER; DISSECTOR INSERT

Model Number	SP8368
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results of the x-rays confirmed that no pieces fell into the patient during the procedure.The snowden-pencer maryland dissector insert subject of the reported event was returned to steris for evaluation.Upon inspection of the device, it was observed that the pin that secures the rod and jaw together was fractured and the jaw on the device was found to be broken off.Due to the evidence of mechanical overstress damage with the returned device, the reported event is attributed to excessive force during use.The following warning can be found in the snowden-pencer maryland dissector insert ifu, "avoid mechanical shock or overstressing the devices; this will cause damage." a steris account manager conducted in-service training with user facility personnel on the proper use and operation to the snowden-pencer maryland dissector insert.The device history record for the subject lot was reviewed and confirmed the device was manufactured to specifications; no abnormalities were noted.A complaint review was conducted for this lot of products and confirmed this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported during a patient procedure with their snowden-pencer maryland dissector insert the pin that holds the rod and jaw together "came out".The procedure was completed successfully utilizing an additional device.Report of procedure delay.No report of injury.The patient received medical intervention (x-rays) following the reported event as a precaution.

• Brand Name: SNOWDEN-PENCER
• Common Device Name: DISSECTOR INSERT
• Manufacturer (Section D): STERIS DEUTSCHLAND GMBH; kantstrasse 33/1; wurmlingen, baden-wurttemberg, D-785 73; GM D-78573
• Manufacturer (Section G): STERIS DEUTSCHLAND GMBH; kantstrasse 33/1; wurmlingen, baden-wurttemberg, D-785 73; GM D-78573
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 24203868
• Report Number: 3006554912-2026-00002
• Device Sequence Number: 15868575
• Product Code: GCJ
• UDI-Device Identifier: 10885403171994
• UDI-Public: (01)10885403171994(10)K21
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K991928
• 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): 01/28/2026

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: SP8368
• Device Catalogue Number: SP8368
• Device Lot Number: (10)K21
• 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: 12/29/2025
• Initial Report FDA Received Date: 01/28/2026
• 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