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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Tissue Damage (2104)
Event Type  Injury  
Manufacturer Narrative
Patient id, date of birth and weight were not provided for reporting. Date of event is unknown. This report is for an unknown proximal femoral nail antirotation-ii. Part#, lot# and udi # is not available. Dates of implant/explant are unknown. Device is not expected to be returned for manufacturer review/investigation. Reporter contact number was not provided. This report is for an unknown proximal femoral nail antirotation-ii. 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. Additionally, 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).
Event Description
This report is being filed after the review of the following literature article: hu, s. J. Et. Al. (2016). Pfna-ii protrusion over the greater trochanter in the asian population used in proximal femoral fractures. Indian journal of orthopaedics, 50(6), 641. China. The study was conducted with the aim to determine whether the proximal segment length of the current proximal femoral nail antirotation-ii (pfna-ii) was suitable for the greater trochanter height. This study was conducted based on the retrospective assessments of postoperative radiograph measurements and clinical records of fifty-one (51) consecutive patients with per/intertrochanteric fractures that were treated with pfna-ii between july 2012 and december 2012. These fifty-one (51) patients were selected based on the inclusion criteria of being >
sixty (60) years of age, fracture being treated with closed reduction and pfna-ii fixation, and lastly getting standard pelvic ap radiographs taken within two (2) weeks postoperatively. The pfna-ii nails implanted were systematically selected such that they were as thick and long as possible, provided that the nail could be manually inserted into the femoral canal without additional distal segment reaming. The most commonly used nail was the short-sized nail, measuring 200 mm in length and 10 mm in diameter. The study population included of nineteen (19) male and thirty-two (32) female patients; average age being 78. 6 years (rage 66-92 years). Twenty-seven (27) cases involved the left hip and twenty-four (24) cases involved the right hip. The causes of injuries were described as low energy violence, which included falling while standing in forty-three (43) cases and pedestrian accidents in eight (8) cases. After being implanted with the pfna-ii, the patients were checked for having lateral trochanter pain after their fracture was healed during the follow-ups at four (4) weeks, eight (8) weeks, three (3) months, six (6) months and one (1) year after operation. Five (5) patients died within one (1) year of the initial pfna-ii implant surgery and four (4) patients were unable to walk or stand independently or with an orthopedic walker. The remaining forty-two (42) patients were followed-up at an average of 15 +- 2. 6 months, and these patients were reported to be able to walk independently or with a stick. The following complications were identified with the use of pfna-ii postoperatively: nail protrusion was observed in forty-five (45) out of fifty-one (51) patients; fifteen (15) being males and twenty-nine (29) being females. Thirty-one (31) out of fifty-one (51) patients had protrusions greater than five (5) mm; eight (8) being males and twenty-three (23) being females. Thirteen (13) patients had lateral trochanter pain on the injured side. Protrusion was reported to be approximately 11. 13 mm in these patients with lateral trochanter pain as compared to the other twenty-nine (29) without pain having about 3. 87 mm of protrusion. Four (4) patients were unable to walk or stand independently or with an orthopedic walker. Five (5) patients were reported to have died within one (1) year of the initial implant surgery. Concomitant devices reported: unknown helical blade (part# unknown, lot# unknown, quantity# unknown). (b)(4) captures 10 of the 47 impacted products. Remaining devices are captured in linked complaints: (b)(4). This report is for an unknown proximal femoral nail antirotation-ii. This is report 7 of 10 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 Key7411935
MDR Text Key105152331
Report Number8030965-2018-52934
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCH
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 03/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2018
Is this an Adverse Event 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 Received03/14/2018
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: 04/10/2018 Patient Sequence Number: 1