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

Model Number 283512

Device Problems Electrical Shorting (2926); Device Contamination with Chemical or Other Material (2944)

Patient Problem Not Applicable (3189)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional narrative: investigation summary: the device was received and evaluated at the service center.The reported complaint that the device had intermittent operation, was confirmed.It was found that the there was a short circuit in the motor cable.There were also traces of fluid inside the device.The defective motor cable was replaced and the device was repaired, tested and found to be fully functional.Fluid ingress into the device would have caused the short circuit in the motor cable.The defective motor cable would have resulted in the complaint reported by the customer.A manufacturing record evaluation was performed for the finished device (serial number : (b)(4)), and no non-conformances were identified.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 affiliate via email that while using the micro tornado hp w handcontrol for removing the remaining acl stump it suddenly stopped and buttons didn't work anymore.We tried to make it work with the foot-pedal but no luck.So we opened the 2d shaver hp to continue the surgery.After the procedure was done, we tested it again after turning the shaver blade, it worked for a while and stopped again.No patient consequences.There was a surgical delay of 15 minutes reported.The device is available to be returned for evaluation.

• 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): MITEK RAYNHAM MFG; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 10116436
• MDR Text Key: 194171476
• Report Number: 1221934-2020-01492
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705016938
• UDI-Public: 10886705016938
• Combination Product (y/n): N
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• 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: 05/12/2020
• Date Manufacturer Received: 05/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1