MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. PRESS MCO820 FOR EAR IMPLANT MARTIN; PFM11

Catalog Number MCO820

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

Device history record (dhr) - the dhr was reviewed and no anomalies related to the reported failure was observed.The press for ear implant (mco820) was returned for evaluation: failure analysis - the evaluation was unable to conclusively verify the complaint as valid; therefore, an investigation for cause was unable to be performed.There are scratches and impacts on the devices.The device did not close completely, but it is compliant with the specifications, as it is normal that this reference does not close completely.No functional defect was found.Root cause - the devices are compliant with the specifications, this complaint is unconfirmed.The reported event is probably due to an improper use of the device or a wrong knowledge of this device.

Event Description

A facility reported that there was a slack at one end of the press for ear implant (mco820), tightening was not done correctly and the device did not close completely.The device was in contact with a patient and the malfunction led to surgical delay of 30 minutes.Another brand instrument was used to complete the procedure.This event occurred in (b)(6) 2021; exact date is unknown.However, there was no patient injury.

• Brand Name: PRESS MCO820 FOR EAR IMPLANT MARTIN
• Type of Device: PFM11
• 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 ; 6099362319
• MDR Report Key: 12092581
• MDR Text Key: 261920596
• Report Number: 2523190-2021-00135
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MCO820
• Device Lot Number: 4595909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Date Manufacturer Received: 06/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1