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

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TFNA HELICAL BLADE 90MM STERILE 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
 

OBERDORF SYNTHES PRODUKTIONS GMBH TFNA HELICAL BLADE 90MM STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.038.290S
Device Problem Unintended Movement (3026)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
Patient information is unknown. Date of event: unknown. Device has not been reported as explanted. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. A review of the device history records has been requested. 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 europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, open reduction internal fixation was applied to femoral trochanteric fractures. On (b)(6) 2018, the cut-out of trochanteric fixation nail advanced (tfna) helical blade in question was found. The surgeon commented that improper reduction might have caused this event. Concomitant device reported: 12mm/125 deg ti cann tfna 170mm ¿ sterile (part 04. 037. 212s, lot h285727, quantity 1). This is report 1 of 1 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTFNA HELICAL BLADE 90MM STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7574632
MDR Text Key110325816
Report Number8030965-2018-54154
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.038.290S
Device Lot NumberH422230
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/25/2017
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: 06/06/2018 Patient Sequence Number: 1
-
-