MAUDE Adverse Event Report: Aspen Surgical Products, Inc. RapidClean® Rongeur, 40° Up, Ceramic Coated, Convertible, 3

Model Number	59-3200-BD
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was returned for evaluation.Visual inspection showed that the gold screw is loose.The customer indicated that they are unsure whether the ssu adjusted the screw prior to sterilization.During manufacturing, loctite is applied to the screw threads, and the screw is also secured with a welding spot to achieve proper jaw alignment by locking the instrument in place so that it does not become unassembled as shown in the customer image.The root cause is user error, for removing the screw during ssu, which broke the loctite and spot welds resulting in the gold screw becoming loose after ightening.If any additional relevant information is identified it will be submitted in a supplemental report.

• Brand Name: RapidClean® Rongeur, 40° Up, Ceramic Coated, Convertible, 3
• Common Device Name: Rongeur
• Manufacturer (Section D): Aspen Surgical Products, Inc.; 6945 southbelt dr se; caledonia MI 49316
• Manufacturer Contact: terry hall ; 6945 southbelt dr se; caledonia, MI 49316 ; +1(616)698-7100
• MDR Report Key: 50057671
• Report Number: 3002750084-2026-00080
• Device Sequence Number: 10657195
• Product Code: HTX
• UDI-Device Identifier: 00887482106136
• UDI-Public: 00887482106136
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2026

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: 59-3200-BD
• Device Lot Number: 82400550
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/27/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 08/26/2026
• 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