MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. SYMMETRY® RONGEUR, DECKER MICRO, STRAIGHT, 152 MM

Model Number	53-4000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.In addition, the customer had the device modified by a third party, but the modification is unknown.After evaluation, it was observed that the area where the top jaw broke off has beach marks indicating fatigue failure.This happens when an initiation crack forms under the surface or on tip of the surface where there is high stress concentration.As the device continues to be used and high force/stress is applied, the crack starts to expand resulting in a fracture as shown.When using a rongeur, it is essential that small bites are made when removing bone/cartilage.If the jaws are overloaded with bone/cartilage it puts a lot of stress on the part which starts or speeds up the fatigue process.The root cause is user error.This should be considered the final report.If any additional relevant information is identified it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "we have received a complaint regarding instrument 53-4000.The clamp broke off inside the patient's intervertebral disc.".

• Brand Name: SYMMETRY® RONGEUR, DECKER MICRO, STRAIGHT, 152 MM
• 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 ; 6166987100
• MDR Report Key: 25230070
• Report Number: 3002750084-2026-00047
• Device Sequence Number: 20117783
• Product Code: HAE
• UDI-Device Identifier: 00887482023440
• UDI-Public: 00887482023440
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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: 53-4000
• Device Lot Number: 224228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/20/2026
• 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