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

Model Number 283512

Device Problem Material Frayed (1262)

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

Event Date 10/06/2020

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 the cable of the device was stripped. Per service reports, this complaint can be confirmed. It was found during evaluation that the motor was corroded, and the motor cable sheath was cut. Further, the keyboard resistance value 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. User mishandling, most probably during cleaning process might be responsible for cut in cable sheath. 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 other identified failures. The corroded motor, defective motor cable and keyboard would have caused the customer to experience the reported problem. 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 06/29/2019 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. 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.

Event Description

It was reported by the customer in (b)(6) that during an unknown surgery on (b)(6) 2020, it was observed that the cable on the handpiece device was stripped. During in-house engineering evaluation, it was determined that the motor on the device was corroded. Another like device was used to complete the procedure without delay. There were no adverse patient consequences reported. 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: 11109204
• MDR Text Key: 224818493
• Report Number: 1221934-2021-00002
• Device Sequence Number: 1
• Product Code: HRX
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 12/31/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 283512
• Device Catalogue Number: 283512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/31/2020
• 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