MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD RUGGLES MICRO DISSECTOR ROUND 7 1/2 INCHES; MICROSURGICAL INSTRUMENTATION

Catalog Number	RN6202
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ruggles micro dissector round 7 1/2 inches (rn6202) was not returned to the manufacturer; therefore, an evaluation of the device could not be performed.A definitive root cause cannot be determined.The issue of device being dull may be the result of customer preference.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
It was reported that the ruggles micro dissector round 7 1/2 inches (rn6202) was "blunt and not as sharp as it should be".It was reported that there was an increase in surgery time of over 30 minutes, as the "doctor had to open his old set to use" to finalize the surgery.No patient injury or death occurred.

• Brand Name: RUGGLES MICRO DISSECTOR ROUND 7 1/2 INCHES
• Common Device Name: MICROSURGICAL INSTRUMENTATION
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 22378951
• Report Number: 3014334038-2025-00089
• Device Sequence Number: 8300796
• Product Code: GZX
• UDI-Device Identifier: 10381780458906
• UDI-Public: 10381780458906
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2025

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 Catalogue Number: RN6202
• Device Lot Number: AV2310
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 07/01/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown