MAUDE Adverse Event Report: STERIS CORPORATION V. MUELLER; RETRACTOR BLADE HANDLE

Model Number	T-1295
Medical Device Problem Codes	Mechanical Jam (2983); Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure a screw to their shadow-line side loading locking retractor blade handle would not fully loosen to allow the retractor blade to attach.A procedure delay was reported as another retractor blade had to be utilized to complete the procedure.No report of injury.
Additional Manufacturer Narrative
The device subject of the reported event is being returned for evaluation.Investigation in progress.A follow-up report will be submitted once additional information becomes available.
Additional Manufacturer Narrative
The device subject of the reported event was not returned for evaluation; however, photographs of the device were provided by the user facility for investigation purposes.Upon follow-up with user facility personnel and review of the photographs it was observed that the device had thread damage indicative of excessive force during use.The t-1295 shadow-line side loading locking retractor blade handle instructions for use states, "avoid mechanical shock or overstressing the devices." the device history record was reviewed and confirmed the lot was manufactured to specifications; no abnormalities were noted.A steris account manager offered in-service to the user facility on the proper use and operation of the t-1295 shadow-line side loading locking retractor blade handle and is pending a response.
Additional Manufacturer Narrative
A steris account manager counseled user facility personnel on the proper use and operation of the t-1295 shadow-line side loading locking retractor blade handle, specifically the importance of avoiding mechanical shock or overstressing the device during use.No additional issues have been reported.

• Brand Name: V. MUELLER
• Common Device Name: RETRACTOR BLADE HANDLE
• 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: 20363805
• Report Number: 1923569-2024-01013
• Device Sequence Number: 6869087
• Product Code: GZT
• UDI-Device Identifier: 10885403175510
• UDI-Public: (01)10885403175510(10)K16
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K964402
• 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,Followup
• Report Date (Section B): 10/03/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: T-1295
• Device Catalogue Number: T1295
• Device Lot Number: (10)K16
• 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: 09/18/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 12/23/2024; 02/04/2025
• 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