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U.S. Department of Health and Human Services

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

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DEPUY MITEK LLC US MICRO TORNADO HP W HANDCONTROL LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM Back to Search Results
Catalog Number 283512
Device Problem Intermittent Continuity (1121)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2018
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Investigation summary: the device was sent to the service center for repair. The defect reported by the customer has been verified and repaired. This complaint is confirmed. On inspecting the device, further deficiencies were found to be impairing device function. The motor does not turn and has been replaced. There was a short circuit in the motor cable, the motor cable was replaced. The resistance value of the keypad assembly was out of specification, the hand control was replaced. The root cause for the reported failure is likely the short circuit in the motor cable. A device history record (dhr) review has been conducted to determine if there were any internal processing issues, which would have contributed to the nature of the product complaint. Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed. The complaint device has been repaired and is fully functional. At this point, 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. Udi: (b)(4).
 
Event Description
It was reported by the affiliate that the motor shaver stops irregularly. No impact on the patient reported. Event occurred post-operatively. The procedure has been completed with a similar device.
 
Manufacturer Narrative
Date received by manufacturer on the initial report should be december 21, 2018. 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.
 
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Brand NameMICRO TORNADO HP W HANDCONTROL
Type of DeviceLINE-POWERED ARTHROSCOPIC SHAVER SYSTEM
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key8196453
MDR Text Key131520111
Report Number1221934-2018-55825
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number283512
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/24/2019
Is This a Reprocessed and Reused Single-Use Device?

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