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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK, INC. METRX RETRACTOR TUBES & DILATORS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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MEDTRONIC SOFAMOR DANEK, INC. METRX RETRACTOR TUBES & DILATORS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/29/2020
Event Type  malfunction  
Event Description
Tubes used for dilating incision for minimally invasive portion of case were dirty on the inside with a residual substance.Instrument was contaminated and used on patient.Surgeon aware, instrument returned to sterile processing by main or sterile core coordinator.During procedure, particles appeared in the field when using the medtronic metrx dilator set.The instruments were ran through and cleaned.Sterile processing department (spd) swabbed inside of tube to check again (brown/ grey residue on the swab).Cleaned instruments numerous times and swab continued to come out with residue.Medtronic sent a loaner tray from another facility.Swab test showed same residue.Medtronic sent new set: swab test, few tubes had rust, and swab test on these and all others showed residue.Medtronic has filed a risk assessment.
 
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Brand Name
METRX RETRACTOR TUBES & DILATORS
Type of Device
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK, INC.
1800 pyramid place
memphis TN 38132
MDR Report Key10717817
MDR Text Key212488809
Report Number10717817
Device Sequence Number1
Product Code LXH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/19/2020
Date Report to Manufacturer10/22/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/22/2020
Type of Device Usage Unknown
Patient Sequence Number1
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