• 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 - NAILS: PFNA 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 - NAILS: PFNA ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Break (1069)
Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Non-union Bone Fracture (2369)
Event Type  Injury  
Manufacturer Narrative
Pma/510k: this report is for an unknown nails: pfna/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k 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
Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: b. , et al (2021) should pertrochanteric and subtrochanteric fractures be treated with a short or long intramedullary nail, j bone joint surg am. Volume 103, number 24, pages 2291-2298(denmark). This study aims to compare the rates of reoperation in elderly patients with pertrochanteric and subtrochanteric fractures that had been treated with a short or long intramedullary nail. Between march 1, 2008, and december 31, 2013, 11 orthopaedic departments across denmark, all adhering to the national guideline from 2008 that was turned into a visual algorithm demonstrating high reliability15-17. All departments had the same postoperative protocol, and the surgical procedures that were included in this study. The present study included 3,154 fractures 2,245 patients (1,655 females and 590 males) with pertrochanteric fractures and 909 subtrochanteric fractures that had been treated with an intramedullary nail. Of the 2,245 pertrochanteric fractures, 1,867 (1,392 females and 475 males) were treated with a short intramedullary nail and 378 ( 263 females and 115 males) were treated with a long intramedullary nail. Of the 909 subtrochanteric fractures, 308 were treated with a short intramedullary nail and 601 were treated with a long intramedullary nail. Mortality: pertrochanteric fractures short intramedullary nail 30-day :227 1 year: 606 long intramedullary nail 30-day :46 1 year: 127 mortality: subtrochanteric fractures short intramedullary nail 30-day :38 1 year: 101 long intramedullary nail 30-day 78 1 year: 193. Pertrochanteric fractures short intramedullary nail major reoperations: pfna (n
=
6), failure was the main reason for reoperation and infection was the second-most-common reason for reoperation. Subtrochanteric fractures short intramedullary nail major reoperations: pfna (n
=
6), failure was the main reason for reoperation and infection was the second-most-common reason for reoperation. Subtrochanteric fractures long intramedullary nail major reoperations: recon (n
=
1), failure was the main reason for reoperation and infection was the second-most-common reason for reoperation. This report is for unknown synthes pfna and unknown synthes recon. This is report 1 of 4 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNK - NAILS: PFNA
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14987479
MDR Text Key295701902
Report Number8030965-2022-04761
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeDA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2022
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
Date Manufacturer Received07/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/12/2022 Patient Sequence Number: 1
-
-