MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. HOOK CEV2295A 3PK N5 FOR HOOK HANDLE; PFM16

Catalog Number	CEV2295A
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hook cev2295a 3pk n5 for hook handle (cev2295a) was returned for evaluation: the device history record (dhr) was not reviewed because the lot/serial numbers were not available.Failure analysis: investigation findings of the five hooks reveal that some of the hooks were more damaged than others and were returned by the customer.The blue coating is melted onto the ends of the hooks.Some coatings are blistered; another has a black deposit.The metal tip of one of the hooks is blackened.Root cause analysis: this is probably due to the use of too high a voltage or a prolonged activation of the device.The hook whose coating is blackened has most likely been in contact with another instrument.A corrective and preventive action (capa) has been raised to investigate this issue and is pending corrective action.
Event or Problem Description
A facility reported that the hook cev2295a 3pk n5 for hook handle (cev2295a) tips melted at the distal part of the blue insulation on the hook side.The tips are new and in their first use, the metal part blackened rather quickly.The distributor has asked the customer to ensure that the monopolar voltage used is reasonable and referred them to the relevant instructions for use.Although the product was in contact with the patient, there were no injuries or an increase in surgical time reported.

• Brand Name: HOOK CEV2295A 3PK N5 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: 23524276
• Report Number: 3003249645-2025-00050
• Device Sequence Number: 9140636
• Product Code: GEI
• UDI-Device Identifier: 10381780092551
• UDI-Public: 10381780092551
• 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
• Report Date (Section B): 11/11/2025

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: CEV2295A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 11/11/2025
• 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
• Patient Sex: Unknown