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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES MONUMENT 11.0MM TI TROCH FIXATION NAIL SCREW/105MM - STERILE ROD,FIXATION,INTRAMEDULLARY

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SYNTHES MONUMENT 11.0MM TI TROCH FIXATION NAIL SCREW/105MM - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.032.105S
Device Problem Failure to Advance (2524)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/14/2017
Event Type  malfunction  
Manufacturer Narrative
Additional device product code: hwc. (b)(4). Due to the intra-operative events, the device was not successfully implanted. An alternate device was used to complete procedural step. As such, implant/explant dates are not applicable. Device is not expected to be returned for manufacturer review/investigation. 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. Device was used for treatment, not diagnosis. 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 a helical blade would not go through a nail during a trochanteric fixation nail (tfn) procedure on (b)(6) 2017. As the surgeon attempted to insert the helical blade, the blade went one-quarter of the way through the nail and would not advance any farther. A lag screw was also tried and that also would not go through the nail. While attempting to back the helical blade out of the nail, the threads of a blade guide sleeve and a buttress compression nut were damaged. It was confirmed that the nail packaging and etching stated "130 degrees. " the same was confirmed for the aiming arm. The construct was taken out and alignment was confirmed. Subsequently, the original nail was replaced with a different nail, and the construct was successfully implanted without issue. There was a reported surgical delay of 15 minutes to remove the original nail. No additional x-rays or additional medical intervention were required. The procedure was successfully completed with the patient in stable condition. Concomitant devices reported: 130 deg aiming arm f/ trochanteric fixation nails (part number 357. 366, lot number unknown, quantity 1). This report is for one (1) 11. 0mm ti troch fixation nail screw/105mm - sterile. This is report 2 of 2 for complaint (b)(4).
 
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Brand Name11.0MM TI TROCH FIXATION NAIL SCREW/105MM - STERILE
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES MONUMENT
1051 synthes ave
monument CO 80132
Manufacturer (Section G)
SYNTHES MONUMENT
1051 synthes ave
monument CO 80132
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6558674
MDR Text Key74911414
Report Number1719045-2017-10450
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092646
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 04/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.032.105S
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 Received04/14/2017
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: 05/10/2017 Patient Sequence Number: 1
Treatment
AIMING ARM (PART # 357.366, LOT # UNKNOWN, QTY 1)
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