MAUDE Adverse Event Report: DEPUY MITEK LLC US MICRO TORNADO HP W HANDCONTROL; LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM

Catalog Number 283512

Device Problems Self-Activation or Keying (1557); Device-Device Incompatibility (2919); Electrical Shorting (2926)

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 reported complaint that the device does not turn due to a jammed motor and that the head was damaged was confirmed.It was found that screws were missing in the head locking mechanism.Also it was found that there was a short circuit in the motor cable and that the device shuts off the pump during operation.Also the blade doesn't lock into the shaver and gets disassembled during use.The damaged and the missing parts of the drill mounting mechanism were replaced along with the motor cable and the device was cleaned, tested and found to be fully functional.User mishandling of the device is one possible root cause for the missing screws and damage to the head locking mechanism.However, given the information provided we cannot discern a definitive root cause for the short circuit.The short circuit would have caused the device to shut off the pump, during operation.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 (b)(6) 2019 and passed all functional testing before being returned to the customer.At this point in time, no corrective action is required, and no further action is warranted.Depuy 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.Udi:(b)(4).

Event Description

It was reported by the affiliate that the motor of the micro tornado hp w handcontrol is jammed, doesn´t turn.It has also a damaged head, it holds the blade or burr in place.The procedure has been completed by using a replacement device.No patient consequences reported, no surgical delay.

• Brand Name: MICRO TORNADO HP W HANDCONTROL
• Type of Device: LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9474133
• MDR Text Key: 207587071
• Report Number: 1221934-2019-59980
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705016938
• UDI-Public: 10886705016938
• Combination Product (y/n): N
• Reporter Country Code: LO
• 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: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 283512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Date Manufacturer Received: 12/05/2019
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1