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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA Ø8.2MM TI ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX/280MM/LT-STER; ROD,FIXATION,INTRAMEDULLARY

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SYNTHES USA Ø8.2MM TI ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX/280MM/LT-STER; ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.031.929S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Staphylococcus Aureus (2058)
Event Date 06/04/2015
Event Type  Injury  
Manufacturer Narrative
Lot number: unknown.Expiration date: unknown - unable to determine without a lot number.The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Literature article received: this report is being filed after the subsequent review of the following literature article.Hashem,j.Et al (2015) "atypical femur fractures in a patient with pycnodysostosis: a case report.Osteoporos int 26:pp.2209-2212.A (b)(6) female presented to the emergency room 29 weeks gravid and unable to ambulate following minor trauma to the left thigh preceded by a 1-month history of increasing thigh pain.She was diagnosed with pycnodysostosis in early adolescence and had a history of lower limb stress fractures treated with long-term casting.Radiographs revealed a transverse femoral shaft fracture with lateral beaking and thickened cortices.The contralateral femur also showed signs of cortical thickening and lateral beaking, raising concern for an impending fracture.Delaying surgery until after birth was ruled out after obstetric consultation.The patient was consented for open reduction and internal fixation of the left femur with an intramedullary (im) nail.An 8.2 mm by 280 mm adolescent-sized, lateral-entry nail (synthes, (b)(4)) was placed over the guide wire and locked using two proximal screws and two distal screws.Four weeks after surgery, the patient presented with persistent drainage from the proximal incision, erythema, and a 2-cm dehiscence.Ultrasound revealed a collection extending to the fascia.The incision was partially opened and a 10-ml sample of seropurulent fluid collected for cultures.Despite antibiotics, the patient experienced worsening pain and drainage.She returned to the emergency department later that same week for irrigation and debridement.The wound was packed, and she was given intravenous antibiotics.Cultures revealed (b)(6) in the wound.She complained of pain in her ankles; bilateral tibia/fibula radiographs revealed anterior cortical thickening consistent with old stress fractures.Approximately 1 week later, she returned after a fall left her with more severe pain in the right thigh.X-rays did not show further damage to the femur.Due to the difficulty with the initial intramedullary fixation, the second surgery was planned as a plate fixation under combined spinal and epidural anesthesia.Lateral breaking was evident upon exposure of the site.This is report 1 of 1 for (b)(4).This report is for an 8.2mm by 280mm adolescent-sized, lateral entry nail.A copy of the literature article is being submitted with this medwatch.
 
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Brand Name
Ø8.2MM TI ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX/280MM/LT-STER
Type of Device
ROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5415850
MDR Text Key37623393
Report Number2520274-2016-10867
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK070843
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,litera
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number04.031.929S
Other Device ID Number(01)10886982094278
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/14/2016
Initial Date FDA Received02/08/2016
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 Outcome(s) Required Intervention;
Patient Age36 YR
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