MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.0MM MULTIBLADE PLUS 5PK ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Model Number 283439

Device Problem Infusion or Flow Problem (2964)

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

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

The serial/lot number is unknown, therefore, the udi is: (b)(4). Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. No additional information was provided.

Event Description

It was reported by the affiliate in (b)(6) that during a knee arthroscopy procedure, it was observed that the 4. 0 mm multiblade plus device shaver clogged often. Another like device was used to complete the surgery. There were no adverse consequences to the patient. No additional information could be provided.

• Brand Name: 4.0MM MULTIBLADE PLUS 5PK
• Type of Device: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 10968744
• MDR Text Key: 220491003
• Report Number: 1221934-2020-03813
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K131191
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 283439
• Device Catalogue Number: 283439
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial