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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US 8022 HAND PC TORNADO SHAVER -NS LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM

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DEPUY MITEK LLC US 8022 HAND PC TORNADO SHAVER -NS LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM Back to Search Results
Catalog Number 288022
Device Problem Suction Failure (4039)
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) as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported by the affiliate in (b)(6) that during an unspecified surgical procedure, it was observed that the 8022 hand pc (b)(6) shaver device did not aspire. It was not reported if there were any delays in the surgical procedure. A spare device was used to complete the surgery. 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.
 
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. If additional information should become available, a supplemental medwatch will be submitted accordingly. 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 additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
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. If additional information should become available, a supplemental medwatch will be submitted accordingly. The date device returned to manufacturer was reported as 12/7/2018 in the previous report and has been updated as 11/30/2018. Investigation summary: the device was received at the service center and evaluated. "tornado": preventive replacement of o-rings performed motor does not turn: motor replaced defective o-rings replaced unit cleaned functional test performed functional test acc. To test procedure completed safety test checklist enclosed electrical safety test completed hipot test completed per the input check report, the root cause for the reported complaint was stuck motor. The device was fully repaired. A review of the device history record indicated that this lot of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed. At this point in time, 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.
 
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Brand Name8022 HAND PC TORNADO SHAVER -NS
Type of DeviceLINE-POWERED ARTHROSCOPIC SHAVER SYSTEM
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key8121655
MDR Text Key128957698
Report Number1221934-2018-55489
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
Report Date 11/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number288022
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2018
Is This a Reprocessed and Reused Single-Use Device? No

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