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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC MANUAL ORTHOPEDIC SURGICAL INSTRUMENT; TAP, BONE
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MEDTRONIC SOFAMOR DANEK USA, INC MANUAL ORTHOPEDIC SURGICAL INSTRUMENT; TAP, BONE Back to Search Results
Catalog Number 8670045
Device Problem Material Frayed (1262)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/02/2014
Event Type  malfunction  
Event Description
It was reported that the patient underwent a posterior thoracic fusion at t5-9 to treat a burst fracture.It was reported that the tip was frayed during use.No patient complications were reported.
 
Manufacturer Narrative
(b)(4): the tip of tap is splayed.This appears to have occurred because the tap was off axis with the guide wire.
 
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Brand Name
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
Type of Device
TAP, BONE
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer Contact
huzefa mamoola
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key4343099
MDR Text Key18734354
Report Number1030489-2014-04787
Device Sequence Number1
Product Code HWX
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 12/05/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8670045
Device Lot NumberIT10A001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2014
Date Manufacturer Received12/05/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/15/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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