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
Event or Problem Description
A facility reported that the hook cev2295a 3pk n5 for hook handle (cev2295a) melted at its ends.It is unknown whether there was patient involvement, injury, death, or surgical delay.
Additional Manufacturer Narrative
The hook cev2295a 3pk n5 for hook handle (cev2295a) was returned for evaluation: failure analysis: the customer returned six hooks; one of them was not coated at integra microfrance (imf), the lightest blue.The blue coating had melted on the ends of the hooks.Some coatings were blistered; another had a black deposit.Another has been rubbed with an abrasive material, presumably during cleaning.Root cause analysis: the blistering is probably due to the use of too high a voltage or a prolonged activation of the device.The hook whose coating was blackened was most likely in contact with another instrument.The coating was scratched by the use of an overly abrasive material during the cleaning.A corrective and preventive action (capa) has been raised to investigate this issue and is pending corrective action.

• 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: 23631387
• Report Number: 3003249645-2025-00054
• Device Sequence Number: 10291923
• 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): 11/24/2025

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: 11/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 11/24/2025
• 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