MAUDE Adverse Event Report: DEPUY MITEK LLC US 8022 HAND PC TORNADO SHAVER -NS; LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM

Catalog Number 288022

Device Problem Incomplete or Inadequate Connection (4037)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the device was received and evaluated at the service center.The complaint was confirmed.The drill mounting mechanism was found to be disassembled relative to the expected configuration per the missing and damaged components of the assembly, therefore the drill mounting mechanism was repaired.The defective o-rings were replaced.The motor was found to be corroded, therefore it was replaced.Fluid contact with the motor has the potential to cause corrosion of the motor, therefore is a potential root cause for the motor being corroded.The o-rings were most likely damaged due to user mishandling.The last time the device was serviced, there were no issues observed with the drill mounting mechanism.Furthermore, there were no modifications or upgrades made to the drill mounting mechanism due that evaluation that would contribute to the condition the drill mounting mechanism was found in during the most current service evaluation.With this, the drill mounting mechanism was most likely caused by user mishandling.The service history has been reviewed in lieu of the device history record for this device since it was previously serviced.The device was last serviced on 10/19/2018 and passed all functional testing before being returned to the customer.At this point, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.(b)(4).

Event Description

It was reported by the affiliate via phone that the tornado shaver handpiece needs service.The device's head is damaged and does not hold burrs.There was patient involvement but no impact to the patient.The issue was found post-operatively.The outcome of the event was the procedure had been completed with no surgical delay.A replacement device was used to complete the procedure.

• Brand Name: 8022 HAND PC TORNADO SHAVER -NS
• Type of Device: LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM
• 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: 8515120
• MDR Text Key: 145540132
• Report Number: 1221934-2019-56853
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705018345
• UDI-Public: 10886705018345
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 288022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Date Manufacturer Received: 03/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1