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

Catalog Number 283512

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.The reported complaint of a defective motor was confirmed.The following information was reported via the service report: "micro": preventive replacement of o-rings performed acc.To service manual.Motor too loud - motor replaced.Protective conductor resistance out of tolerance - motor cable replaced.Resistance value out of specs: handcontrol set replaced.Defective drill mounting mechanism 1.0 has been replaced by 1.25.Unit cleaned.Functional test performed.Hipot test completed.Electrical safety test completed.Functional test acc.To test procedure completed.Safety test checklist enclosed.The motor was found to be noisy, the handcontrol was not responding properly, the locking ring did not close properly, the value of the keypad assy was drifting, and the protective earth resistance was out of range.However, specific root causes for the identified defects cannot be determined.These devices are frequently sent in for repair due to the nature of their use, and longevity in the field.The device is categorized under legacy manufacturing.A review of lot/batch history for each legacy fms product complaint is not recommended since legacy manufacturing no longer exists, and it is no longer possible to make process corrections or corrective actions.At this time, no corrective action is required and no further action is warranted.However, depuy mitek will continue to track any related complaints within this device family to monitor the extent to which this complaint is observed in the field.

Event Description

It was reported by the affiliate in (b)(6) that post-operatively to an unknown procedure, it was observed that the micro tornado handpiece with handcontrols did not turn and that motor was jammed.During in-house engineering evaluation, it was determined that the device had a defective drill mounting mechanism.It was reported that a spare device was used to complete the procedure without delay.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown but was noted to have occurred in 2018.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• 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: 8164589
• MDR Text Key: 130491459
• Report Number: 1221934-2018-55669
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• 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: 10/09/2018
• Date Manufacturer Received: 12/12/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1