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

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.

• 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 Key: 5415850
• MDR Text Key: 37623393
• Report Number: 2520274-2016-10867
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK070843
• Number of Events Reported: 1
• 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 Number: 04.031.929S
• 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 Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR