MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. SCREW SLEEVE CEV7145B6 5.5MM 100MM; PFM16

Catalog Number	CEV7145B6
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 2 of 2 for the screw sleeve (cev7145b6) used during this event and is related to mfg number: 3003249645-2024-00045.It was reported that when the trocar 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 led to an increase in surgery time.
Additional Manufacturer Narrative
The screw sleeve (cev7145b6) was returned for evaluation: failure analysis: evaluation of the screw sleeve verified the complaint reported by the customer as valid.The trocar was broken in two.Root cause analysis: it was determined that the breakage was likely due to excessive force applied during assembly and use with the trocar head.
Event or Problem Description
N/a.

• Brand Name: SCREW SLEEVE CEV7145B6 5.5MM 100MM
• 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: 20209200
• Report Number: 3003249645-2024-00046
• Device Sequence Number: 7450103
• Product Code: HET
• UDI-Device Identifier: 10381780095217
• UDI-Public: 10381780095217
• 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): Unknown
• 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: CEV7145B6
• Device Lot Number: 5921656
• 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: 10/22/2021
• 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