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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ossification (1428); Non-union Bone Fracture (2369)
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). (other number) udi: unknown part number, udi is unavailable. 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 4 of 14 for (b)(4). This report is for an unknown universal synthes nail and refers to the serious injury for case #35, (b)(6) patient who experienced heterotopic ossifications and malunion.
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Manufacturer (Section D)
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
MDR Report Key5394011
MDR Text Key36915063
Report Number2520274-2016-10404
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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 Received01/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Other Device ID NumberUNKNOWN
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 Received01/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 01/27/2016 Patient Sequence Number: 1