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	10/22/2024
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 the dia 5mm tungsten needle holder (cev738t5) broke during use and a fragment fell into the patient.The doctor indicated that the failure occurred during suture, without any constraints applied on the instrument.It is unknown whether fragments were removed.No injury, death or surgical delay occurred.
Additional Manufacturer Narrative
Updated fields: d4 (primary udi#), d9, g3, g6, h2, h3, h4, h6, h11.The dia 5mm tungsten needle holder (cev738t5) was 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 tungsten needle holder verified the complaint reported by the customer as valid.The movable jaw was broken.Root cause analysis: it was noted that uses requiring the application of excessive force, as well as successive cleanings could have weakened the instrument and caused it to break.

• 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: 20667649
• Report Number: 3003249645-2024-00054
• Device Sequence Number: 12887353
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2024

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: CEV738T5
• Device Lot Number: 7205123
• 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: 10/23/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 12/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2023
• 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