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

Model Number 283512

Device Problem Crack (1135)

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

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that cable of the device was ripped off.Per service reports, this complaint can be confirmed.It was found during evaluation that the motor was corroded.Further, the motor cable and keyboard resistance value were out of tolerance limits.The motor, motor cable and keyboard were replaced to resolve the issues.After repair, the device was found to be working according to the specifications.Fluid ingress into the device and contact with the motor is responsible for the rusty motor.With the available information, we cannot determine the root cause of the defective motor cable and defective keyboard.The corroded motor and defective motor cable and defective keyboard would have caused the customer to experience the reported problem.This serialized device ((b)(4)) was manufactured prior to the current manufacturer, therefore a dhr review cannot be performed since the original manufacturer no longer exists and therefore the manufacturer can no longer make any process correction or corrective actions if needed.At this point in time, 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.Device history lot: a review of lot/batch history for each legacy fms product complaint received by mitek chu is not recommended since legacy manufacturing no longer exists, and it is no longer possible to make process corrections or corrective actions.This device (serial number: (b)(4)) was produced prior to the closure of the fms facility in nice, france and therefore will not have a dhr review preformed.Please see signed legacy fms batch review.

Event Description

It was reported by the affiliate in (b)(6) that the cable on the micro tornado hp w handcontrol device was ripped off.During in-house engineering evaluation, it was determined that the motor was rusty.There was no procedure involved.There were no adverse patient consequences.No additional information was provided.

• 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): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 11039258
• MDR Text Key: 222817429
• Report Number: 1221934-2020-03946
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705016938
• UDI-Public: 10886705016938
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 283512
• Device Catalogue Number: 283512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Date Manufacturer Received: 12/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1