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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES (USA) TFNA HELICAL BLADE 90MM STERILE ROD, FIXATION, INTRAMEDULLARY

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SYNTHES (USA) TFNA HELICAL BLADE 90MM STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.038.290S
Device Problem Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/24/2016
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis. (b)(4). The subject device is not expected to be returned to the synthes manufacturer for evaluation. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 that there was a positioning issue with a trochanteric fixation nail - advanced (tfna) blade during surgery on (b)(6) 2016. During surgery to treat a femur fracture, the nail and blade were already implanted, the surgeon tried to use the compression nut and as he tried to spin it to gain compression, the blade pulled out of the medial segment of bone (i. E. The femoral head). The distance from the tip of the blade to the subchondral bone in the femoral head had an undesired increase. A popping sound was heard, but the cause undetermined. Traction was taken off at the point. It was noted it should have been removed earlier. Some compression was gained through continued turning of the compression nut, as well as through mallet strikes on the coupling screw. The blade, nail and screws were left implanted in patient, and no instruments were loose or were retained in the patient. The surgical delay was less than three minutes. The patient's condition was stable at the end of the surgery and the procedure was completed successfully. This report is 1 of 1 for (b)(4).
 
Manufacturer Narrative
Device was used for treatment, not diagnosis. (b)(6). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand NameTFNA HELICAL BLADE 90MM STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES (USA)
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
terry callahan
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5653880
MDR Text Key45156739
Report Number2520274-2016-12681
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.038.290S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/24/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/13/2016 Patient Sequence Number: 1
Treatment
(B)(4), 3.2MM WIRE GUIDE SLEEVE
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