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	12/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The dia 5mm tungsten needle holder (cev738t5) has been returned for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Failure analysis: evaluation of the needle holder verified the complaint reported by the customer as valid.The movable jaw was broken.Root cause analysis: it was determined that uses requiring the application of excessive force as well as successive cleanings could have weakened the instrument and caused it to break.
Event or Problem Description
It was reported that the jaw of the dia 5 mm tungsten needle holder (cev738t5) broke in the belly of a patient.There was a 30-minute increase of surgery time, to find the broken piece in the patient's abdomen.All parts were reportedly removed.The operating room team changed the needle holder in order to complete the intra-abdominal sutures.No patient injury occurred.

• 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: 21095179
• Report Number: 3003249645-2024-00062
• Device Sequence Number: 8732322
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/07/2025

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: 7351876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• 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