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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 Problems Intermittent Continuity (1121); Electrical Shorting (2926); Suction Failure (4039)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2018
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 pre-operatively to an unknown procedure the micro tornado handpiece with hand controls has poor suction volume. The customer complaints that competitor shaver have better suction efficiency. Intermittent failure. Repair quotation approval needed before repair. Who was involved (e. G. Patient, user, etc. )-n/a. The outcome of the event, outcome to the patient(s) and/or users-unknown. The procedure was completed but unknown how. Unknown, if any troubleshooting or phone fix performed as well as the outcome of it will be documented in the event description.
 
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. Udi: (b)(4).
 
Event Description
Additional information received from affiliate on 20november2018: it was reported it is unknown if there was a surgical delay, how the case was completed, if alternatives were readily available, or what type of procedure it was. Additional information received from affiliate on 17december2018: it was confirmed the device had been sent back and there was no additional information available.
 
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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 Key8061467
MDR Text Key126993421
Report Number1221934-2018-55268
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,Followup,Followup,Followup
Report Date 10/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2018
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 Manufacturer11/01/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2019
Is This a Reprocessed and Reused Single-Use Device?

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