• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Device Problems Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616)
Patient Problem No Code Available (3191)
Event Date 01/12/1999
Event Type  Injury  
Manufacturer Narrative
Device was used for treatment, not diagnosis. This report is for unknown pfn system/unknown quantity/unknown lot. (b)(4). 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. (b)(4).
Event Description
Literature article received: this report is being filed after the subsequent review of the following literature article: simmermacher, r. , bosch, a. , van der werken, c. (1999). The ao/asif-proximal femoral nail (pfn): a new device for the treatment of unstable proximal femoral fractures. Injury, international journal of the care of the injured, 30, 327-332. Netherlands. Purpose of study: the study was held in 1996 by four european hospitals to evaluate the handling qualities of the proximal femoral nail (pfn) and to compare the early postoperative results with the results of comparable devices. Patient demographic: the study involved 190 patients, 52 male and 138 female, with a mean age of 76. 6 (range 17-97), with 191 trochanteric femoral fractures. 20 fractures were classified as 31-a1 (stable), 128 as 31-a2 (unstable pertrochanteric) and 42 as 31-a3 (intertrochanteric fractures). The classification of one fracture was unknown. Complete 4 month follow up was conducted for 152 patients (a1- group 16, a2-group 105, a3-group 31 patients). In 104 patients (68%) the postoperative course was uneventful. During the observation period 29 patients (19%) died of causes not related to the implant. Type of surgery: surgery for the treatment of unstable proximal femoral fracture with the proximal femoral nail (pfn). Implants used: proximal femoral nail; load bearing neck screw; antirotational hip pin and a distal locking screw. Complications reported: serious injury/reportable malfunction: technical failures requiring revision surgery were seen with malrotation (two), the wrong choice of screw length (five), cut-out (one patient returned involuntarily to the hospital three months postoperatively after a fall from a bridge) and dynamization of the implant (four). Most of the complications appeared in the group of unstable proximal femoral fractures. This is report 2 of 2 for (b)(4). This report is for an unknown pfn system.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Manufacturer (Section D)
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
terry callahan
1302 wrights lane east
west chester, PA 19380
MDR Report Key5821105
MDR Text Key50387320
Report Number2520274-2016-13619
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,litera
Reporter Occupation
Type of Report Initial
Report Date 07/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2016
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/07/2016
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: 07/25/2016 Patient Sequence Number: 1