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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES ELMIRA 11.0MM TI HELICAL BLADE 85MM ROD, FIXATION, INTRAMEDULLARY

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SYNTHES ELMIRA 11.0MM TI HELICAL BLADE 85MM ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 456.302
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
Additional narrative: patient weight is unknown. Event date: unknown. Additional product code: hwc. Device was either implanted on (b)(6) 2012 or (b)(6) 2014. Date of manufacture: january 03, 2014. A review of the device history record revealed no complaint related anomalies. The device history record shows lot 7572112 of 11. 0mm ti helical blade 85mm was processed through the normal manufacturing and inspection operations with no scrap or rework noted. This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition. A review of the raw material device history record(s) determined the raw material lot 7160371 met all specifications. 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 7 of 15 for (b)(4).
 
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Brand Name11.0MM TI HELICAL BLADE 85MM
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES ELMIRA
35 airport road
horseheads NY 14845
Manufacturer (Section G)
SYNTHES ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5364680
MDR Text Key35916540
Report Number3003506883-2016-10009
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 Number456.302
Device Lot Number7572112
Other Device ID Number(01)10886982226655(10)7572112
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 Manufactured01/03/2014
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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