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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 380MM/LEFT ROD, FIXATION, INTRAMEDULLARY

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SYNTHES MONUMENT 11MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/LEFT ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 456.419S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Non-union Bone Fracture (2369)
Event Type  Injury  
Manufacturer Narrative
Additional device product code: hwc. (b)(4). Patient was implanted in 2016 about six to eight months (6-8) ago, exact date was unknown. Device is not expected to be returned for manufacturer review/investigation. Device history record review concluded that (part #: 456. 419s, lot#: 7729589 (sterile) - 11mm/130 deg ti cann troch fixation nail 380mm/left - sterile. Quantity 5. No non-conformance reports (ncrs) were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Sterility documentation was reviewed and determined to be conforming. )manufacturing location: (b)(4),manufacturing date: july 09, 2014 and expiration date: may 31, 2023. 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 patient was originally implanted with a 11. 0mm/130 degree titanium trochanteric fixation nail (tfn) left, a 11. 0mm titanium helical blade, and an unknown 5. 0mm locking screw on an unknown date on about six to eight months (6-8) ago to repair a left femur fracture. On (b)(6) 2016, the patient was returned to the operating room in to remove the devices after it was identified that the patient presented with a non-union. The complained devices were successfully removed and the patient was implanted with a 6 hole dynamic hip screw (dhs) and an unknown number of unknown screws. The surgery was successfully completed without any surgical delay and no adverse events were reported against the patient. This is report 1 of 3 for (b)(4).
 
Manufacturer Narrative
Device was used for treatment, not diagnosis. (b)(4). 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 Name11MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/LEFT
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 Key6110182
MDR Text Key60241472
Report Number1719045-2016-10833
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
Type of Report Initial,Followup
Report Date 10/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number456.419S
Device Lot Number7729589
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 Received12/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/09/2014
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: 11/17/2016 Patient Sequence Number: 1
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