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

Catalog Number 283512

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

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 at the service center and evaluated.On inspecting the device, deficiencies were found to be impairing device function and the reported complaint was confirmed.The housing was damaged.The insulation resistance of the motor was outside tolerance.It was also noted that the motor does not turn.There was a cut in the motor cable and there was a short circuit in the motor.Also the resistance values of the keypad of the handcontrol were out of specifications.It was also noted that the cupstyle washer was loose.The handle, motor, motor cable and the handcontrol set were replaced.The complaint device was cleaned, repaired and tested for functionality.Also preventive replacement of o-rings was performed.The housing damage is most likely caused by user mishandling.However, given the information provided we cannot discern a definitive root cause for the other identified failures.A manufacturing record evaluation was performed for the finished device [serial: (b)(4)] number, and no non-conformances were identified.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.Udi: (b)(4).

Event Description

It was reported by the affiliate that the micro tornado handpiece with hand controls needs service.The device does not turn as the motor is jammed.There was patient involvement but no impact on 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: 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 ; 6103142063
• MDR Report Key: 8686998
• MDR Text Key: 148024795
• Report Number: 1221934-2019-57323
• 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: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• 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: 04/15/2019
• Date Manufacturer Received: 05/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1