MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. CABLE CP391M 3.5M MONOPOLAR MARTIN; PFM16

Catalog Number	CP391M
Medical Device Problem Codes	Overheating of Device (1437); Explosion (4006); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
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 total knee prosthesis and arthroplasty change operation, the 3.5m monopolar martin cable (cp391m) exploded and the tip was cut.It was subsequently reported that while using the monopolar electric scalpel with a multi-purpose tip, it "exploded." it was noted that the power cable between the electric scalpel, and the generator had a broken thread.A small "explosion" was heard, and observantly, it was noted that the electric scalpel cable had been cut (overheating?) near the handpiece (of the monopolar electric scalpel tip).It was reported that the device was not in contact with the patient.Another product was used to complete the procedure.No injury, death, or surgical delay occurred.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h11.The cable cp391m 3.5m monopolar martin (cp391m) was returned for evaluation: the device history record (dhr) was reviewed, and no abnormalities related to the reported issue were observed.Failure analysis: the cable cp391m 3.5m monopolar martin was received in used condition.Upon evaluation, it was verified that the cable was cut.There were no signs of an explosion, as the customer indicated.The cable was sent to the subcontractor for further investigation.Root cause analysis: the product was returned, and upon evaluation, it was confirmed that the cable was damaged due to being cut.Potential root causes include: the cable may have come in contact with a sharp object in the operating room, or a power surge may have caused the cable to break.However, no definitive root cause can be determined without further investigation by the subcontractor.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h6, h11.Unable to review the applicable device history record (dhr) because the cable is not a microfrance cable.The sutter investigation shows that the cable is not a sutter cable, it does not correspond to a reference sold by microfrance.The customer provided a lot number, but it does not match this cable.This claim is not subject to input by integra microfrance.

• Brand Name: CABLE CP391M 3.5M MONOPOLAR MARTIN
• 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: 22106220
• Report Number: 3003249645-2025-00020
• Device Sequence Number: 15507764
• Product Code: GEI
• UDI-Device Identifier: 10381780099512
• UDI-Public: 10381780099512
• Combination Product (Y/N): N
• PMA/510(K) Number: K073450
• 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
• Report Date (Section B): 09/04/2025

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: CP391M
• Device Lot Number: 22430220
• 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: 05/07/2025
• Supplement Date Received by Manufacturer: 07/01/2025; 09/01/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 07/04/2025; 09/04/2025
• 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