MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. HOOK CEV229-4A 3PK N3 FOR HOOK HANDLE; PFM16

Catalog Number	CEV229-4A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h4, h6, h11.The hook cev229-4a 3pk n3 for hook handle (cev229-4a) was not returned for evaluation: the device history record (dhr) was reviewed, and no abnormalities related to the reported issue were observed.Failure analysis: although product or objective evidence was not returned, the picture sent by the customer shows that the coating is melted at the end of the tip.Root cause: this is probably due to the use of too high a voltage or a prolonged activation of the device or contact with another metallic instrument.Corrective action and preventive action (capa)-00294 is being processed to confirm the root cause of this problem.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h11.Corrected field: g4: pma/510(k) #.
Event or Problem Description
N/a.
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 the insulation tip of hook cev229-4a 3pk n3 for hook handle (cev229-4a) completely broke off during a surgical procedure.The tip was recovered.It is unknown whether the tip fell into the surgical site.No patient injury and a minimum surgical increase of less than 30 minutes were reported.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h11.The customer reported that "the insulation of the tip was completely broken; however, the photo provided by the customer indicates that the coating had melted.
Event or Problem Description
N/a.

• Brand Name: HOOK CEV229-4A 3PK N3 FOR HOOK HANDLE
• Common Device Name: PFM16
• 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: 22436345
• Report Number: 3003249645-2025-00031
• Device Sequence Number: 16944188
• Product Code: GEI
• UDI-Device Identifier: 10381780092544
• UDI-Public: 10381780092544
• Combination Product (Y/N): N
• PMA/510(K) Number: K210942
• 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,Followup,Followup
• Report Date (Section B): 01/27/2026

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: CEV229-4A
• Device Lot Number: 7286766
• 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: 06/17/2025
• Supplement Date Received by Manufacturer: 07/22/2025; 10/24/2025; 01/09/2026
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 07/31/2025; 10/24/2025; 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2023
• 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