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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES MONUMENT 12MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/LEFT-STER ROD,FIXATION,INTRAMEDULLARY

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SYNTHES MONUMENT 12MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/LEFT-STER ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 456.481S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Additional patient information: patient height reported as 5 feet 5 inches. (b)(6). Additional device product code: hwc. (b)(4). Device is not expected to be returned for manufacturer review/investigation. (b)(4). Device history record review for part #: 456. 481s, lot#: 7867789 (sterile) - 12mm/130 deg ti cann troch fixation nail 400mm/left - sterile. Quantity (b)(4): manufacturing location: (b)(4), manufacturing date: 19 dec 2014, expiration date: 30-nov-2023. 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. 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 is reported patient was implanted with a 12mm x 400mm trochanteric fixation nail (tfn)-left, one (1) 90mm lag screw, and two (2) 5. 0mm distal locking screws on (b)(6) 2015. On unknown date, patient reported pain. Patient was returned to surgery on (b)(6) 2016 where surgeon removed all hardware. All explanted hardware was intact. Surgery was completed successfully with no delay and no harm to patient. It is reported surgeon plans to wait a few weeks, then revise patient to a total hip implant. This is report 1 of 3 for (b)(4).
 
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Brand Name12MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/LEFT-STER
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
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6142836
MDR Text Key61396602
Report Number1719045-2016-10876
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
Report Date 11/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number456.481S
Device Lot Number7867789
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 Received11/08/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/19/2014
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: 12/02/2016 Patient Sequence Number: 1
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