• 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 TFNA HELICAL BLADE PERF L85 TAN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

  • 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 TFNA HELICAL BLADE PERF L85 TAN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.038.385S
Device Problem Migration (4003)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Additional product code: ktt, appliance, fixation, nail/blade/plate combination, multiple component complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a j&j employee. 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
It was reported that on (b)(6) 2021, the patient underwent surgery for trochanteric fracture of femur with the tfna implants in question. The surgery was completed successfully with no surgical delay. Over-sliding occurred a few weeks after the surgery, so the fixation was maintained thereafter. But approximately 3 weeks ago, the patient started to complain pain. It was confirmed by x-ray that the position of the blade in the bone head moved to the proximal side of the bone head. The head was probably inverted or rotated. The patient underwent careful rehabilitation and was followed up, but the change in the position of the blade did not stop, so it was decided that the revision surgery via bha would be performed before cut-out occurred. The surgeon attributed the cause of the event to lack of fixation ability due to improper reduction at the initial surgery. The surgeon does not consider the event to be causally related to the products. No further information is available. This complaint involves one (1) device tfna helical blade perf l85 tan. This is report 1 of 1 for complaint (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTFNA HELICAL BLADE PERF L85 TAN
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13652970
MDR Text Key286453069
Report Number8030965-2022-01282
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.038.385S
Was Device Available for Evaluation? No
Date Manufacturer Received02/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/02/2022 Patient Sequence Number: 1
Treatment
LOCKSCR Ø5 L38 F/NAILS TAN LIGHT GREEN; TROCHANT FEM NAIL 10 125 L20
-
-