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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES MONUMENT 10MM/125 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE ROD, FIXATION, INTRAMEDULLARY

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SYNTHES MONUMENT 10MM/125 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 456.314S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Swelling (2091); Impaired Healing (2378)
Event Type  Injury  
Manufacturer Narrative
Patient weight is unknown. Date of event: unknown. (b)(4). Device was either implanted on (b)(6, 2012 or (b)(6) 2014. Manufacturing location: (b)(4). Manufacturing date: june 25, 2014. Expiration date: may 31, 2023. No non-conformance reports 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 was reported that due to infection, non-union, and red swollen of left thigh that was draining through small open wound around femur, patient was revised on (b)(6) 2015 to removed hardware from (b)(6) 2012 and (b)(6) 2014. All hardware was removed intact. Patient was treated with possible infection and an antibiotic nail was made by the surgeon and implanted in the medullary canal. Procedure was successfully completed and no surgical delays were reported. Patient will return to operating room at later date, once infection has cleared for revision fixation. Patient/status outcome was reported as fine. This is report 1 of 15 for (b)(4).
 
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Brand Name10MM/125 DEG TI CANN TROCH FIXATION NAIL 170MM-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
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5363632
MDR Text Key35796467
Report Number1719045-2016-10054
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK011857
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 12/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number456.314S
Device Lot Number7712128
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 Received12/24/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/25/2014
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: 01/13/2016 Patient Sequence Number: 1
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