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Device Problem Unintended Movement (3026)
Patient Problems Pain (1994); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Date of event is unknown. This report is for one (1) unknown pfna blade. Pma/510(k) number is not available. Part#, lot# and udi # is not available. Implanted, explanted dates: unknown. Device is not expected to be returned for manufacturer review/investigation. This report is for one (1) unknown ffna blade. Pma/510(k) number is not available. Pma/510(k) number is not available. Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Device history records review could not be completed without lot number. 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. [(b)(4) carulli, c. Literature article. Pdf].
Event Description
This report is being filed after the subsequent review of the following literature article, carulli, christian and et al. (2017) "a comparison of two fixation methods for femoral trochanteric fractures: a new generation intramedullary system vs sliding hip screw". Clinical cases in mineral and bone metabolism, 2017; 14 (1):40-47. (italy). A prospective study was performed on (140) consecutive patients affected by a trochanteric fracture treated by internal fixation with either proximal femoral nail antirotation (pfna) or dynamic hip screw (dhs) between january 2007 to december 2009. Two groups were created; group a that had pfna treatment and was composed of 71 patients (29 male, 42 female with mean age of 81. 6 years) and group b that had dhs treatment and was composed of 69 patients (25 male, 44 female, with mean age of 83. 4 years) all subjects were evaluated with clinical and radiologic follow up. Two (2) patient were lost to follow up after the 3 month evaluation and four (4) patients did not attend the last follow up visit in total from the study. Group a pfna complications: death. Two (2) patients died; (one (1) patient died related from pulmonary embolism 9 days after surgery, the other died of unknown causes) serious injury. One (1) case of pulmonary infection. Two (2) cases of deep vein thrombosis (dvt). Five (5) cases of non-union at 6 months post-operatively with reports of pain and limited range of motion. Seven (7) cases of periarticular ossification discovered during postoperative follow up. Serious injury and device malfunction: one (1) case of implant failure (nail cut out) one month after surgery in an (b)(6) year old patient (reported pain and required revision surgery). Two (2) cases of spiral blade medial migration through the femoral head. One (1) case of lateral protrusion of the blade with trochanteric bursitis. This complaint captures the events from the pfna (group a); (b)(4) captures the events from the dynamic hip screw (dhs) system (group b). This report is for one (1) unknown proximal femoral nail antirotation (pfna) blade. This is report 3 of 4 for (b)(4).
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Manufacturer (Section D)
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
michael cote
1302 wright lane east
west chester, PA 19380
MDR Report Key7335294
MDR Text Key102315995
Report Number8030965-2018-52005
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeIT
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 02/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/13/2018 Patient Sequence Number: 1