• 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: TFNA HELICAL BLADE 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: TFNA HELICAL BLADE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Malunion of Bone (4529)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). This report is for an unk - nail head elements: tfna helical blade/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 as no product was received. The investigation could be completed, no product was received; no conclusion could be drawn at the time of filing this report. 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
It was reported that on (b)(6) 2021, the patient underwent revision surgery due to the tfna was being removed due to nonunion/ malunion. The surgery was successfully completed. The patient outcome is unknown. This complaint involves four (4) devices. This report is for (1) unk - nail head elements: tfna helical blade this is report 3 of 4 or complaint (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE
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 Key12990228
MDR Text Key284730900
Report Number8030965-2021-10175
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 Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2021
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
Date Manufacturer Received11/15/2021
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: 12/13/2021 Patient Sequence Number: 1
Treatment
UNK - END CAPS: TFNA; UNK - NAILS: TFNA; UNK - SCREWS: LOCKING
-
-