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

Catalog Number 283512

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2019

Event Type  malfunction  

Manufacturer Narrative

(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 complaint device was received at the service center and was evaluated.The reported complaint by the customer that the handpiece was not working was confirmed.The handpiece was found to be defective.It was further found that the drill mounting mechanism was defective.The burr was hard to be installed.The motor was corroded and did not turn.The bend protection of the motor cable was damaged.The resistance value of the keypad of the handcontrol set was out of specifications.Also the contacts of the keypad were corroded and the buttons didn't function.The defective drill mounting mechanism was replaced.Also the motor, motor cable, and the handcontrol set were replaced.The complaint device was cleaned, repaired and tested for functionality.Fluid contact with the motor has the potential to cause corrosion of the motor, therefore is a potential root cause for the motor being corroded.When the motor is corroded, it has the potential to stick and not turn.The fluid ingress would also have contributed to the corrosion of the keypad contacts, resulting in the damage to the handcontrol set, which in turn, would have caused the resistance values to go out of specifications and the buttons to not function.However, given the information provided we cannot discern a definitive root cause for the defective cable and drill mounting mechanism.A manufacturing record evaluation was performed for the finished device (serial: (b)(4)), 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.(b)(4).

Event Description

It was reported by the affiliate via mail that micro tornado handpiece with hand control was not working.The issue was found post-operatively at the end of the surgery when there is no need of handpiece.The procedure was completed with no patient harm or surgical delay.

• 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: 8728496
• MDR Text Key: 149190465
• Report Number: 1221934-2019-57419
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705016938
• UDI-Public: 10886705016938
• Combination Product (y/n): N
• Reporter Country Code: JO
• 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: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 04/17/2019
• Initial Date Manufacturer Received: 06/20/2019
• Initial Date FDA Received: 06/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1