MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. NEEDLE HOLDER CEV738T5 DIA 5MM TUNGSTEN; PFM16

Catalog Number CEV738T5

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 Description

A facility reported that during an unspecified surgical procedure, the needle holder cev738t5 was found to be defective.The device was in contact with the patient; however, there was no patient injury or surgical delay.

Manufacturer Narrative

The needle holder cev738t5 was returned for evaluation: device history record (dhr) - the dhr was reviewed and no anomalies that could be associated with the complaint incident was observed.Failure analysis - the evaluation verified the complaint as valid.The traction wire is broken at the drilling pin.There is a crack all along the wire.This defect is not visible to the naked eye.Root cause - the issue is due to a material defect.There is no adverse trend; however, an investigation is in progress with the material supplier and the investigation will be reopened if additional information is received.

• Brand Name: NEEDLE HOLDER CEV738T5 DIA 5MM TUNGSTEN
• Type of Device: PFM16
• Manufacturer (Section D): INTEGRA MICROFRANCE S.A.S.; le pavillon; le pavillon; saint aubin le monial 03160 ; FR 03160
• MDR Report Key: 11942866
• MDR Text Key: 261707279
• Report Number: 2523190-2021-00118
• Device Sequence Number: 1
• Product Code: HET
• Combination Product (y/n): N
• PMA/PMN Number: K080257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CEV738T5
• Device Lot Number: 5419619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Date Manufacturer Received: 07/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1