MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. TONGUE DEPRESSOR 7803S-2 N2 KILNER; PFM11

Catalog Number	7803S-2
Medical Device Problem Codes	Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	06/04/2025
Type of Reportable Event	Serious Injury
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
It was reported that during a surgical procedure requiring the use of a kilner tongue depressor, the tongue depressor 7803s-2 n2 kilner (7803s-2), the surgeon observed a wound on the tongue that required suturing.The location of the lesion coincides with the point of contact of the device.It was reported that during inspection of the blades, the surgeon noted that they had a particularly sharp edge.No death or surgical delays were reported.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h11.The tongue depressor 7803s-2 n2 kilner (7803s-2) was returned for evaluation: the device history record (dhr): unable to review the applicable dhr as the batch number was not available.Failure analysis: the tongue depressor 7803s-2 n2 kilner.Upon further inspection, it was discovered that the angles are salient and cutting.The instrument presents differences compared to the model.It says microfrance, but it's a different marking than the one currently used.There's also no small, circled r (®), no batch number, and the product code was not written in the same font as microfrance.The edges of the instrument are protruding, and the chute appears to be welded, while the others are a single piece.Root cause analysis: the reported complaint was confirmed.Impossible to determine with certainty the root cause of this problem: this instrument does not have a lot number, and there was no sales record at the customer or at integra.The client thinks that the instrument can be 20-30 years old.The instrument may come from another manufacturer or have been modified at a different provider.

• Brand Name: TONGUE DEPRESSOR 7803S-2 N2 KILNER
• Common Device Name: PFM11
• Manufacturer (Section D): INTEGRA MICROFRANCE S.A.S.; le pavillon; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer (Section G): INTEGRA MICROFRANCE S.A.S.; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 22782330
• Report Number: 3003249645-2025-00036
• Device Sequence Number: 9869578
• Product Code: KBN
• UDI-Device Identifier: 10381780089407
• UDI-Public: 10381780089407
• 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): 09/08/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 7803S-2
• 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: 07/22/2025
• Supplement Date Received by Manufacturer: 09/01/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 09/09/2025
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SUTURING OF THE TONGUE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown