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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES MONUMENT 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE; ROD, FIXATION, INTRAMEDULLARY

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SYNTHES MONUMENT 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE; ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 456.318S
Device Problem Fitting Problem (2183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/26/2017
Event Type  malfunction  
Manufacturer Narrative
Patient weight not available for reporting.Additional product code: hwc udi: (b)(4).Device was not explanted.Complainant part 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 on (b)(6) 2017 the patient underwent an open reduction internal fixation (orif) of the femur to treat a fracture.The patient was implanted with devices from both the trochanteric fixation nail advanced (tfna) system and the trochanteric fixation nail (tfn) system using tfna instrumentation.The patient was implanted with a tfn nail and a tfna helical blade.Upon insertion, the helical blade was removed and a shorter 95mm helical blade was implanted.The surgeon had difficulty advancing the set screw although eventually it was advanced.The connection between the insertion handle and the tfna nail was reported as not being a good fit although the instrument was used for its intended purpose.The tfna nail was locked distally although some difficulty was reported.There was a five (5) minute delay due to switching the larger helical blade for a smaller device.No harm was reported to the patient.The procedure was successfully completed.Post-operatively it was confirmed the patient was implanted with a prior generation tfn nail with a tfna helical blade.The off-label use was then discussed with the surgeon.This report is for one (1) trochanteric fixation nail.This is report 1 of 2 for (b)(4).
 
Manufacturer Narrative
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
Upon insertion, the helical blade was removed and a shorter 95mm helical blade was implanted [at the surgeon's discretion].The connection between the insertion handle and the tfn nail was reported as not being a good fit although the instrument was used for its intended purpose.The tfn nail was locked distally although some difficulty was reported.
 
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Brand Name
11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE
Type of Device
ROD, 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 Key6519248
MDR Text Key73739302
Report Number1719045-2017-10345
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011857
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/30/2017
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 Number456.318S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/30/2017
Initial Date FDA Received04/25/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age76 YR
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