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

Model Number 283512

Device Problem Device-Device Incompatibility (2919)

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.Udi: (b)(4).

Event Description

It was reported by the affiliate that during an unknown procedure the cable of the micro tornado hp w handcontrol was damaged and it did not old burs.The procedure was completed using a replacement.No patient consequence and no surgical delay was reported.No additional information was provided.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.Investigation summary
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> the complaint device was received at the service center and evaluated.It was reported that the cable of the microtornado hp handcontrol was damaged and did not hold burs.Per service manual operational and diagnostic, the reported failure was confirmed.During evaluation, the motor cable was found damaged since the cables were exposed; therefore, it was replaced.The insulation was damaged too near the bend protection.In addition, the values of the resistance were out of the range, in consequence the hand control set was replaced.Finally, the buttons were found not functioning, thus the service was completed replacing the buttons.The repair and testing of the unit was completed per the service manual, bringing the unit back to full functionality.The unit passed all functional tests and is fully operational.The possible root cause for the reported failure can be attributed to the damage the unit had which may cause that the unit stopped to working.Also, the short circuit on the motor cable may be as a failure to electrical components, and the buttons failure can be related to lack of maintenance.However, this cannot be conclusively affirmed.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.At this time, no corrective action is required, and no further action is warranted, as the device was repaired and is fully functional.However, depuy synthes 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.Udi: (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.H10 additional narrative: d10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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
• MDR Report Key: 9532336
• MDR Text Key: 199310117
• Report Number: 1221934-2019-60207
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• 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: 12/23/2019
• Date Manufacturer Received: 03/13/2020
• Patient Sequence Number: 1