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)
Type of Reportable Event	Malfunction
Event or Problem Description
Patient four of the reported events- a facility reported that during an impacted wisdom teeth surgical removal, the carbon surgical blades 15 (4-115) fractured inside a patient's mouth, breaking directly at the cutting surface, and is concerned for the operator and presents a significant risk of patient injury, and had experienced this issue on five different occasions over the last six months.All broken pieces were retrieved from the mouth using a surgical snap instrument.There was no report of patient injuries or death, but a minimal surgical delay.
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.
Additional Manufacturer Narrative
Corrected fields: d9, e1 (reporting facility) and (customer primary first and last name), e1 (customer's number and email), g3, g6, h2, h3, h6, h11.The carbon surgical blades 15 (4-115) were not returned for evaluation.The device history record (dhr) was reviewed, and no abnormalities related to the reported issue were observed.Failure analysis: per visual evaluation of the provided image, the 4-115 carbon surgical blades were broken and used.The supplier investigation could not identify a manufacturing or quality error.Retained samples were within specification and passed testing.Damage to the blade may be the result of rough handling or use with an incompatible handle size.No manufacturing, workmanship, or material deficiency has been identified.Root cause analysis: the reported complaint was confirmed.Per the provided image, this 4-115 surgical blade was broken and used.Supplier evaluation of retained samples and production records could not identify a production or quality cause for the reported issue.There was no return of product for additional investigation.Damage to the blade may be the result of rough handling or the use of an incompatible handle size.

• 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: 24392203
• Report Number: 3014334038-2026-00013
• Device Sequence Number: 10622717
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

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: C24H17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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