MAUDE Adverse Event Report: STERIS DEUTSCHLAND GMBH V. MUELLER; T-COAT MICRO HANDLE

Model Number	NL4291-81T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cleanaccess kerrison rongeur t-coat micro handle subject of the reported event was requested to be returned for evaluation.Investigation of the event is currently in progress.A follow-up report will be submitted when 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 a patient procedure the tip of their cleanaccess kerrison rongeur t-coat micro handle "broke".The tip piece was immediately retrieved, and the procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
The cleanaccess kerrison rongeur t-coat micro handle was returned for evaluation.Evaluation results found marks on the slider which indicates the device was improperly repaired by an unauthorized repair agency.The tip of the cleanaccess kerrison rongeur t-coat micro handle that broke during the time of the reported event was not returned.The device history record was reviewed and confirmed the device was manufactured to specifications; no abnormalities were noted.No additional issues have been reported.

• Brand Name: V. MUELLER
• Common Device Name: T-COAT MICRO HANDLE
• 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: 23544743
• Report Number: 3006554912-2025-00001
• Device Sequence Number: 18473423
• Product Code: HAE
• UDI-Device Identifier: 10885403187537
• UDI-Public: (01)10885403187537
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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): 11/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NL4291-81T
• Device Catalogue Number: NL429181T
• Device Lot Number: G21XME
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 02/16/2026; 02/22/2026
• 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