MAUDE Adverse Event Report: SYNTHES USA; ROD,FIXATION,INTRAMEDULLARY

Device Problem Fracture (1260)

Patient Problem Ossification (1428)

Event Date 03/01/2008

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not for diagnosis.This report is for an unknown nail (unknown quantity/unknown lot).The investigation could not be completed; 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

This report is being files after subsequent review of the following literature article: iacovellis, claudia; strukul, leonardo (2008) intramedullary nailing in femoral shaft fractures.Evaluation of a group of 101 cases.Chir organi mov 92:17-21.This clinical study analyses the results obtained with 101 intramedullary locked nails with the aim to establish the limitations and advantages of this technique with respect to the type of nail used, reaming, dynamisation and the possible presence of open fractures from 1 january 1996 to 31 december 2002 were reviewed.The patients were 68 males and 32 females with an average age of 37 years.A total of 50 patients (group a) were studied with complete x-ray documentation (pre-surgery, post-surgery and follow-up); the other 50 patients (51 cases, group b) were studied with clinical documentation (hospital stay and follow-up) and incomplete x-ray documentation.The results for this second group were established during follow-up by the doctor who evaluated the patient with clinical and x-ray examination.Stabilisation was performed with universal synthes nail (62 cases), russel-taylor nail (14), gamma long nail (10), uncannulated femoral nail (ufn) (9), cannulated femoral nail (cfn) (4) and proximal femoral nail (pfn) (2).Reaming technique was used in 91 cases.There were 2 pseudoarthroses: one case no.46 with universal synthes dynamic reamed nail and the second with ufn nail.Malunions were few: 3 shortenings (table 1, cases no.35 and 48, -2 cm; table 2, case no.37, -3 cm) and no axial or rotary problems were found.Heterotopic ossifications were observed with universal synthes nail (12 cases).In conclusion, the results here reported confirm the locking nail system with early dynamisation as the treatment of choice in shaft fractures, especially with new generation nails which, with further improvement, can be expected.This report is 6 of 14 for (b)(4).This report is for an unknown universal synthes nail and refers to the serious injury for case #47, (b)(6) male patient who experienced heterotopic ossifications.

• 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: 5394802
• MDR Text Key: 36957999
• Report Number: 2520274-2016-10409
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/14/2016
• 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: 34 YR