MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CARBON SURGICAL BLADES 15; INSTRUMENTS - CUTTING & DISSECTING

Catalog Number	4-115
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported that the carbon surgical blades 15 (4-115) the blade fell out and into the patient¿s mouth after a single use of the product.No patient injury or surgical delay was reported.
Additional Manufacturer Narrative
Updated fields: g3, g6, d9, h2, h3, h6, h11.The carbon surgical blades 15 (4-115) was returned for evaluation.The device history record (dhr) was reviewed, and no abnormalities related to the reported issue were observed.Failure analysis: the returned 4-115 carbon surgical blades were in unused condition in their original packaging with no visible defect.The blades were unused.The broken blade was not returned for evaluation.Evaluation of the supplier found that the returned items were within specification and functioned properly.The supplier evaluation could not identify a manufacturing cause.No manufacturing, workmanship, or material deficiency could be identified.The reported complaint could not be confirmed.Root cause analysis: the returned 4-115 blades are in unused condition in their original packaging with no visible defect.The blades were found to be within manufacturing specifications.The supplier investigation could not identify any manufacturing or quality issues.The damaged blade was not received for evaluation.Breakage of the blades may be the result of rough handling or use with an incompatible handle size.
Event or Problem Description
N/a.

• Brand Name: CARBON SURGICAL BLADES 15
• Common Device Name: INSTRUMENTS - CUTTING & DISSECTING
• 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: 24240661
• Report Number: 3014334038-2026-00008
• Device Sequence Number: 21376136
• Product Code: GES
• UDI-Device Identifier: 10381780063544
• UDI-Public: 10381780063544
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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 Catalogue Number: 4-115
• Device Lot Number: C24L18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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