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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK METRX; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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MEDTRONIC SOFAMOR DANEK METRX; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Catalog Number 9560524
Device Problems Break (1069); Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/13/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Device evaluation anticipated but not begun.
 
Event Description
It was reported that a flexible arm of metrx couldn't be connected.More specifically, flexible arm support assembly could not connect with bed rail.The product came in contact with the patient.No patient complications were reported.The event extended the surgery for more than 60 minutes.Surgeon's comment: the flexible arm support assembly was stiff from the time of purchase and the flexible arm broke at the second surgery.The event was the most probably due to lack of item inspection at shipping.Sales rep's comment: the connecting part with bed rail was reportedly stiff from the first surgery.Malfunction of the flexible arm assembly cannot be helped as screws inside probably got jammed by force applied from outside.Flexible arm support assembly was stiff when it was connected onto bed rail for the first time after delivery.So the surgeon determined it to be a defect from the time of delivery.Sales rep was not present at the time of delivery.The surgical time extended for 60 minutes.It reportedly resulted because of the delay at the start of the surgery.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
METRX
Type of Device
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer Contact
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key5066687
MDR Text Key26073569
Report Number1030489-2015-02291
Device Sequence Number1
Product Code LXH
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Followup
Report Date 08/19/2015
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
Device Catalogue Number9560524
Device Lot NumberMY15C001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/10/2015
Supplement Dates Manufacturer Received08/19/2015
Supplement Dates FDA Received09/19/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/15/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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