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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC METRX(TM) SYSTEM ARTHROSCOPE

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MEDTRONIC SOFAMOR DANEK USA, INC METRX(TM) SYSTEM ARTHROSCOPE Back to Search Results
Model Number 9560101
Device Problems Crack (1135); Optical Problem (3001)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Evaluation of the returned device was not completed at the time of this report. A follow up report will be sent when analysis is complete. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information received from user facility via medtronic field representative regarding an event happened during intra-op for a procedure re of med or mel. It was reported that a cloudy white turbidity has appeared on the screen. It was mentioned as when looked into the scope, the lens seemed to be cracked. The product came in contact with the patient, but there was no impact to patient reported as a result of this event. There were no symptoms reported to patient as a result of this event. There were no complications to patient/physician were reported/anticipated.
 
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Brand NameMETRX(TM) SYSTEM
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer Contact
tricha miles
1800 pyramid place
memphis, TN 38132
7635140379
MDR Report Key10592306
MDR Text Key208732899
Report Number1030489-2020-01349
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K993021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9560101
Device Catalogue Number9560101
Device Lot Number1301932R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/17/2020
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 Reuse

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