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

Model Number 283512

Device Problem Corroded (1131)

Patient Problem Not Applicable (3189)

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: the device was received and evaluated at the service center.The reported complaint that the hand piece was causing the fms pump connected to it to reset, was confirmed.It was found that the cable of the hand piece was defective and that the hand piece was corroded.The motor cable along with the corroded parts were replaced and the device was repaired, tested and found to be working according to specifications.Fluid ingress into the device is the root cause of the corrosion of the various components of the device.The defective cable and other components would have caused the hand piece to not function as 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 sales rep that during a shoulder repair, a fms pump device stopped working when a fms tornado micro handpiece with buttons was connected to it.A new handpiece was used and this second device was also causing pump to reset.A second pump was brought in and the problem persisted.A third shaver handpiece was used to finish the case with a surgical delay of 35 minutes.No patient consequences reported.During in-house engineering evaluation, it was determined that the micro tornado hp w hand control device was corroded.No additional information was provided.Additional information provided by the affiliate reported "the pump¿s both reset (rebooted) with what was the two shavers that were returned.Both pumps have functioned properly with the third shaver and have work without incident since".

• 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; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 10410856
• MDR Text Key: 203032283
• Report Number: 1221934-2020-02102
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705016938
• UDI-Public: 10886705016938
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• 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: 07/20/2020
• Date Manufacturer Received: 08/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1