MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD RUGGLES MICRO DISSECTOR - SPATULA - SMALL - 7 1/; N/A

Catalog Number	RN6206
Medical Device Problem Codes	Nonstandard Device (1420); Product Quality Problem (1506); No Apparent Adverse Event (3189)
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 - spatula - small -rn6206) 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 the device being the wrong size may be the result of customer preference for another product.If 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 - spatula - small - 7 1/ (rn6206) was not as sharp as expected, it was blunt.There was no patient injury; however, an increase in surgical time, greater than 30 minutes was reported as they had to get the old set for both products.The surgery was completed with another product available at the hospital.
Additional Manufacturer Narrative
Updated fields: b5, g3, g6, h2, h6/f10 (medical device problem codes).
Event or Problem Description
It was reported that the ruggles micro dissector - spatula - small - 7 1/ (b)(6) was smaller than what was previously ordered by the hospital.There was no patient injury; however, an increase in surgical time, greater than 30 minutes was reported as they had to get the old set for both products.The surgery was completed with another product available at the hospital.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h6/f10(medical device problem codes), h11 additional information from the customer received on 02-may-2025 indicated that the size was acceptable.This issue may be the result of user preference.There has been no return of product for evaluation.The definitive root cause cannot be determined.
Event or Problem Description
N/a.

• Brand Name: RUGGLES MICRO DISSECTOR - SPATULA - SMALL - 7 1/
• Common Device Name: N/A
• 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: 22379165
• Report Number: 3014334038-2025-00090
• Device Sequence Number: 12834292
• Product Code: GZX
• UDI-Device Identifier: 10381780458944
• UDI-Public: 10381780458944
• 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,Followup,Followup
• Report Date (Section B): 08/04/2025

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: RN6206
• Device Lot Number: AV2304
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 07/23/2025; 07/30/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 07/28/2025; 08/04/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown