MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. DIA 5MM TUNGSTEN NEEDLE HOLDER; PFM16

Catalog Number	CEV738T5
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that one of the jaws of the dia 5mm tungsten needle holder (cev738t5) broke during a laparoscopic inguinal hernia procedure.It was reported that there was risk of losing a broken part in the patient; however, the broken part was reportedly retrieved and removed.No patient injury, death, or surgical delay was reported.Clarification has been sought regarding the reported incident date.
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.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h11.The dia 5mm tungsten needle holder (cev738t5) was returned for evaluation: the device history record (dhr) was reviewed, and no abnormalities related to the reported issue were observed.Failure analysis: the dia 5mm tungsten needle holder mobile jaw was broken, and the fragment was returned.There were corroded areas in the fracture zone.It suggests the presence of a crack prior to the breakage.There are impacts on the mobile and the fixed jaws, near the base.The spring of the handle is bent.Root cause analysis: the reported complaint was confirmed.The damages are likely due to excessive effort applied to the device during use or reprocessing.This phenomenon is increased by the shape of the jaw: the angle after the fixing part could weaken the jaw and generate a crack.No manufacturing, workmanship, or material deficiency has been identified.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h11.Corrected field: g4: pma/510(k).

• Brand Name: DIA 5MM TUNGSTEN NEEDLE HOLDER
• 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: 22403744
• Report Number: 3003249645-2025-00030
• Device Sequence Number: 8257290
• Product Code: HET
• UDI-Device Identifier: 10381780095378
• UDI-Public: 10381780095378
• Combination Product (Y/N): N
• PMA/510(K) Number: K080257
• 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): 10/24/2025

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: CEV738T5
• Device Lot Number: 7338706
• 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: 05/26/2025
• Supplement Date Received by Manufacturer: 07/09/2025; 10/24/2025
• Initial Report FDA Received Date: 07/04/2025
• Supplement Report FDA Received Date: 07/10/2025; 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• 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