• 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 END CAP EXTENS. 0 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 END CAP EXTENS. 0 TAN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 04.038.000S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bone Fracture(s) (1870)
Event Type  Injury  
Manufacturer Narrative
Product complaint number: (b)(4). Complainant part is not expected to be returned for manufacturer review/investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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. Part: 04. 038. 000s, lot: 272p826, manufacturing site: (b)(4). Release to warehouse date: 26 july 2021. Expiry date: 01 july 2031, a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified. 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: it was reported that on (b)(6) 2021, the patient underwent an open reduction internal fixation with the trochanteric fixation nail- advanced for the fracture of the diaphyseal femur. The surgery was completed successfully without any surgical delay. After the surgery, secondary fracture had occurred. A tfna fenestrated helical blade 90mm ¿ sterile, tfna femoral nail ø11 125° l200 timo15, lockscrew ø5 l34 f/nails tan- light green, and a tfna end cap extension 0 tan were used during the procedure. On (b)(6) 2022, the revision surgery was performed to remove the trochanteric fixation nail- advanced and fix the fracture with a long gamma nail and screws. According to the surgeon, this event was caused by a technical error due to poor implant insertion point, not product malfunction. The surgeon thought that the patient had not fallen. The surgeon guessed that the secondary fracture may be a stress fracture because the insertion point was posterior, and the tip of nail was hitting the anterior cortical bone. No further information is available. The procedure was successfully completed. The patient outcome is reported as stable. This report is for one (1) tfna end cap extension 0 tan. This is report 1 of 4 for complaint (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTFNA END CAP EXTENS. 0 TAN
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14254635
MDR Text Key290456436
Report Number8030965-2022-02844
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,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number04.038.000S
Device Catalogue Number04.038.000S
Device Lot Number272P826
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/26/2021
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/29/2022 Patient Sequence Number: 1
Treatment
LOCKSCR Ø5 L34 F/NAILS TAN LIGHT GREEN; TFNA FEM NAIL Ø11 125° L200 TIMO15; TFNA FENESTRATED HELICAL BLADE 90 - SILE
-
-