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

Model Number 283512

Device Problems Mechanical Problem (1384); Overheating of Device (1437); Use of Device Problem (1670); Output Problem (3005)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 11/08/2021

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported by the sales rep that during a rotator cuff repair surgery on (b)(6) 2021, it was observed that when the button on the micro tornado hp w handcontrol device was pressed, the device made a beeping sound and an error code appeared.It was further reported that the device heated up unexpectedly.Since there was no spare device to use, the case was completed with a delay of 10 minutes as an open procedure instead of an arthroscopic one.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not availble 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 evaluated.It was reported that ¿when the button is pressed to shave the device beeps and an error code appears.Handpiece would not rotate.The device also heats up unexpectedly.¿ per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: ¿ minor scratches on the device ¿ functional : jammed/seized motor(s) the repair of the device was however declined, and it is being placed into long term hold.The faulty parts was identified as the root cause for the device failure during the service evaluation.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.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.

Event Description

It was reported by the sales rep that during a rotator cuff repair surgery on (b)(6) 2021, it was observed that when the button on the micro tornado hp w handcontrol device was pressed, the device made a beeping sound and an error code appeared.It was further reported that the device heated up unexpectedly.According to the report, the device wound not rotate and alarming the console.It was reported that the code would clear but would return if the device was attempted.Since there was no spare device to use, the case was completed with a delay of 10 minutes as an open procedure instead of an arthroscopic one.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: b5, h6: subsequent follow-up with the customer, additional information was received regarding the event.Therefore, the event description and medical device problem code have been updated 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 Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12853890
• MDR Text Key: 281100998
• Report Number: 1221934-2021-03396
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: Yes
• 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: 11/18/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention