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

MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAIL HEAD ELEMENTS ROD, FIXATION, INTRAMEDULLARY

  • 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
 

SYNTHES GMBH UNK - NAIL HEAD ELEMENTS ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Migration (4003)
Patient Problem Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unknown nail head elements unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review investigation. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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.
 
Event Description
This report is being filed after the review of the following journal article: arora, r. , retrospective evaluation of radiological and clinical outcomes after surgical treatment of proximal femur fractures utilizing tfna, vol. Xx (xx), pages 1-6 (austria). The aim of this retrospective study is to evaluate the clinical and radiological outcomes of patients treated with the trochanteric fixation nailing with anti-rotation feature (tfna) and to evaluate intra- and postoperative complications with focus on patients with a minimum follow up of one year. Between september 2014 to december 2018, a total of 276 patients with a mean age of 77. 4 (sd 14. 2) were included in the study. Surgery was performed using trochanteric fixation nail advanced system (tfna). 202 patients (73. 2%) were treated with a short tfna (170 mm, 200 mm and 235 mm), the remaining 74 patients (26. 8%) with a long tfna (260 mm- 480 mm). The most frequently used blade length was 95 mm, additional augmentation with pmma cement was used in 68 cases (25. 0%). The mean follow-up period was unknown. The following complications were reported as follows: 34 patients died within the first 12 postoperative months. 19 patients (6. 9%) required a total of 23 additional surgeries, of which 12 were implant removals (two at the request of the patient, six with consequent arthroplasty), four replacements of the blade, two removals of bony fragments, two wound revisions with debridement, one derotation, one pseudarthrosis remediation and one removal of a loosened bolt. 18 pre-defined failures (6. 5%) recorded are as follows: (b)(6) a (b)(6) year-old female patient had a cut-through. (b)(6) a (b)6) year-old male patient had a lateral protrusion (screw/blade). (b)(6) a (b)(6) year-old female patient had pre-existing femoral head necrosis. (b)(6) a (b)(6) year-old female patient had impending cut-out. (b)(6) a (b)(6) year-old male patient had persistent complaints. (b)(6) an (b)(6) year-old female patient had loosening of a bolt. (b)(6) a (b)(6) year-old female patient had pseudarthrosis. (b)(6) a (b)(6) year-old male patient had pseudarthrosis. (b)(6) a (b)(6) year-old male patient had lateral protrusion (screw/blade). (b)(6) an (b)(6) year-old patient had lateral protrusion (screw/blade). (b)(6) a (b)(6) year-old male patient had impending cut through. (b)(6) an (b)(6) year-old male patient had implant related infections (deep infections). (b)(6) an (b)(6) year-old patient had pseudarthrosis fem. Dext. With implant breakage (b)(6) an (b)(6) year-old patient had lateral protrusion (screw/blade). (b)(6) a (b)(6) year-old male patient had lateral protrusion (screw/blade). (b)(6) a (b)(6) year-old female patient had cut out. (b)(6) a (b)(6) year-old female patient had implant related infections (deep infections). (b)(6) a (b)(6) year-old male patient had malrotation. This report is for an unknown synthes tfna constructs, unknown synthes tfna helical blade, unknown synthes tfna lag screw and unknown synthes screws. This report is for one (1) unk - nail head elements. This is report 7 of 9 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNK - NAIL HEAD ELEMENTS
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11468137
MDR Text Key248769036
Report Number8030965-2021-01888
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 02/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/11/2021
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 Received02/12/2021
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

-
-