MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. SPARE PART CEV127T HEAD TROCAR; PFM16

Catalog Number	CEV127T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This report is 1 of 2 for the trocar head used during this event and is related to mfg number: 3003249645-2024-00046.It was reported that when the trocar head (cev127t) was placed on the abdominal wall, it broke in two, leaving a large part in the abdominal wall.The doctor managed to extract the piece.There was no suspected injury to the patient.It is unknown whether the event lead to an increase in surgery time.
Additional Manufacturer Narrative
The trocar head (cev127t) was returned for evaluation: the device history record (dhr) was reviewed and no anomalies that could be associated with the complaint were observed.Failure analysis: evaluation of the trocar head verified the complaint reported by the customer as valid.The inside of the trocar head was broken root cause analysis: it was determined that the breakage was probably due to excessive force applied during assembly and use with the screw sleeve.
Additional Manufacturer Narrative
Updated fields: d4 (primary udi#), g3, g6, h2, h3, h11.

• Brand Name: SPARE PART CEV127T HEAD TROCAR
• 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: 20209202
• Report Number: 3003249645-2024-00045
• Device Sequence Number: 20695644
• Product Code: HET
• UDI-Device Identifier: 10381780103943
• UDI-Public: 10381780103943
• Combination Product (Y/N): N
• PMA/510(K) Number: K993653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2024

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: CEV127T
• Device Lot Number: 5133995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 11/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2020
• 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