TFN-ADVANCERecalls & reported problems across all models
Synthes GmbH · 195 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
5 open recalls name at least one TFN-ADVANCE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1,031
- Deaths reported
- 1
- Injuries reported
- 768
- Recalls
- 5
We found 195 models of TFN-ADVANCE by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 1,031 adverse event reports in the FDA's MAUDE database, received between Sep 1, 2016 and Sep 25, 2026 — classified as 1 death, 768 injuries, 262 malfunctions.
The most frequently reported specific device problem is “Break” (366 reports).
5 FDA recall records name at least one of these models by its device identifier, 5 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
TFN-ADVANCE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 24, 2024Open, Classified
Products not sterilized, sterility cannot be confirmed
Z-1240-2024 · Root cause: Process control · Recall details · FDA record ↗
- Jan 24, 2024Open, Classified
Products not sterilized, sterility cannot be confirmed
Z-1239-2024 · Root cause: Process control · Recall details · FDA record ↗
- Feb 1, 2023Open, Classified
TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length
Z-1248-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Feb 1, 2023Open, Classified
TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length
Z-1247-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Feb 1, 2023Open, Classified
TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length
Z-1246-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported TFN-ADVANCE problems
Device problems
- Break366
- Adverse Event Without Identified Device or Use Problem224
- Device-Device Incompatibility180
- Migration150
- Material Twisted/Bent29
- Migration or Expulsion of Device20
- Material Deformation13
- No Apparent Adverse Event13
Patient problems
- No Code Available260
- No Clinical Signs, Symptoms or Conditions181
- Failure of Implant159
- Nonunion/Delayed-union Bone Fracture157
- Pain93
- Insufficient Information88
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available79
- Bone Fracture(s)59
TFN-ADVANCE models
195 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- TFN-ADVANCE 04.037.242SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 recall26 reports
- TFN-ADVANCE 04.037.144SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 recall6 reports
- TFN-ADVANCE 04.037.212SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 recall5 reports
- TFN-ADVANCE 04.037.213SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 recall3 reports
- TFN-ADVANCE 04.037.944SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 recall2 reports
- TFN-ADVANCE 04.037.142SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES44 reports
- TFN-ADVANCE 04.037.042SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES37 reports
- TFN-ADVANCE 04.037.159SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES31 reports
- TFN-ADVANCE 04.038.390SAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT26 reports
- TFN-ADVANCE 04.038.395SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES24 reports
- TFN-ADVANCE 04.038.400SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES24 reports
- TFN-ADVANCE 04.038.195SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES23 reports
- TFN-ADVANCE 04.037.160SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES20 reports
- TFN-ADVANCE 04.038.000SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES20 reports
- TFN-ADVANCE 04.037.161SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES18 reports
- TFN-ADVANCE 04.038.385SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES18 reports
- TFN-ADVANCE 04.038.190SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES14 reports
- TFN-ADVANCE 04.038.195APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT14 reports
- TFN-ADVANCE 04.038.200SAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT14 reports
- TFN-ADVANCE 04.038.205SAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT14 reports
- TFN-ADVANCE 04.037.044SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES13 reports
- TFN-ADVANCE 04.038.400ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES13 reports
- TFN-ADVANCE 04.037.156SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES12 reports
- TFN-ADVANCE 04.037.158SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES12 reports
- TFN-ADVANCE 04.037.259SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES12 reports
- TFN-ADVANCE 04.038.390ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES12 reports
- TFN-ADVANCE 04.038.405SAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT12 reports
- TFN-ADVANCE 04.037.045SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES11 reports
- TFN-ADVANCE 04.037.057SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES11 reports
- TFN-ADVANCE 04.037.145SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES11 reports
- TFN-ADVANCE 04.038.380SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES11 reports
- TFN-ADVANCE 04.037.012SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES10 reports
- TFN-ADVANCE 04.037.058SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES10 reports
- TFN-ADVANCE 04.037.263SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES10 reports
- TFN-ADVANCE 04.037.043SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES9 reports
- TFN-ADVANCE 04.037.112SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES9 reports
- TFN-ADVANCE 04.037.257SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES9 reports
- TFN-ADVANCE 04.037.258SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES9 reports
- TFN-ADVANCE 04.037.260SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES9 reports
- TFN-ADVANCE 04.037.261SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES9 reports
- TFN-ADVANCE 04.038.190APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT9 reports
- TFN-ADVANCE 04.037.061SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES8 reports
- TFN-ADVANCE 04.038.085SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES8 reports
- TFN-ADVANCE 04.038.200APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT8 reports
- TFN-ADVANCE 04.037.056SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES7 reports
- TFN-ADVANCE 04.037.059SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES7 reports
- TFN-ADVANCE 04.037.162SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES7 reports
- TFN-ADVANCE 04.037.163SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES7 reports
- TFN-ADVANCE 04.037.461SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES7 reports
- TFN-ADVANCE 04.038.185SAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT7 reports
- TFN-ADVANCE 04.038.300ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES7 reports
- TFN-ADVANCE 04.037.026SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES6 reports
- TFN-ADVANCE 04.037.128SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES6 reports
- TFN-ADVANCE 04.037.157SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES6 reports
- TFN-ADVANCE 04.037.262SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES6 reports
- TFN-ADVANCE 04.038.095SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES6 reports
- TFN-ADVANCE 04.038.290SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES6 reports
- TFN-ADVANCE 04.038.295SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES6 reports
- TFN-ADVANCE 04.038.395APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT6 reports
- TFN-ADVANCE 04.037.028SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- TFN-ADVANCE 04.037.115SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- TFN-ADVANCE 04.037.143SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- TFN-ADVANCE 04.037.265SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- TFN-ADVANCE 04.037.459SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- TFN-ADVANCE 04.037.942SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- TFN-ADVANCE 04.038.090SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- TFN-ADVANCE 04.038.185APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT5 reports
- TFN-ADVANCE 04.038.205ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- TFN-ADVANCE 04.038.285SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- TFN-ADVANCE 04.038.300SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- TFN-ADVANCE 04.038.305SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- TFN-ADVANCE 04.038.310SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- TFN-ADVANCE 04.038.385ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- TFN-ADVANCE 04.038.405APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT5 reports
- TFN-ADVANCE 04.037.015SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- TFN-ADVANCE 04.037.054SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- TFN-ADVANCE 04.037.055SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- TFN-ADVANCE 04.037.060SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- TFN-ADVANCE 04.037.062SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- TFN-ADVANCE 04.037.129SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- TFN-ADVANCE 04.037.228SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 death4 reports
- TFN-ADVANCE 04.037.245SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- TFN-ADVANCE 04.037.256SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- TFN-ADVANCE 04.038.180SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- TFN-ADVANCE 04.038.210APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT4 reports
- TFN-ADVANCE 04.038.210SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- TFN-ADVANCE 04.038.410SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- TFN-ADVANCE 04.037.013SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- TFN-ADVANCE 04.037.024SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- TFN-ADVANCE 04.037.027SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- TFN-ADVANCE 04.037.030SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- TFN-ADVANCE 04.037.031SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- TFN-ADVANCE 04.037.127SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- TFN-ADVANCE 04.037.130SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- TFN-ADVANCE 04.037.152SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- TFN-ADVANCE 04.037.155SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- TFN-ADVANCE 04.037.165SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- TFN-ADVANCE 04.037.254SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- TFN-ADVANCE 04.037.943SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- TFN-ADVANCE 04.038.085ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
Recent TFN-ADVANCE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Device-Device Incompatibility
It was reported that there was rust on items. The items are not able to be sterilized. The Locking holes in plates are compromised/did not lock in surgeries. There was no patient harm or surgical delay.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900096 ↗MalfunctionSep 23, 2026Difficult to Advance
It was reported that the set screw on the proximal end had been pre-deployed. There was no patient harm and no surgical delay.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869866 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient underwent revision surgery due to material failure with proximal migration of the TFNA helical blade despite locking.Upon manufacturers investigation it was noted that the returned Nail revealed that the connection between the nail and the connecting screw was stripped and one the prongs was broken.
Patient problems: Insufficient Information
MAUDE report 50852989 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
It was reported that in 2025, the patient underwent osteosynthesis surgery for femoral shaft fracture with the product in question. Postoperatively, a nonunion developed.On (b)(6) 2026, the patient underwent revision surgery to replace it for femoral pseudarthrosis.The surgery was completed successfully with 180 minutes delay. Multiple fractures were reported in relation to the patient's medical history, treatment history, and other medical conditions currently under treatment.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 50845565 ↗MalfunctionSep 9, 2026Break
It was reported that a TFNA nail has broken. No further information is provided.
Patient problems: Insufficient Information; Nonunion/Delayed-union Bone Fracture
MAUDE report 50696409 ↗InjurySep 1, 2026Break
It was reported during a nail change in the case of a peri-implant femur fracture, it was found that the nail to be replaced had broken through the hole of the femoral neck blade/screw. The nail was implanted on (b)(6) 2025 ,Revision occurred (b)(6) 2026.
Patient problems: Limb Fracture
MAUDE report 50547220 ↗MalfunctionAug 19, 2026Break
Patient problems: Insufficient Information
MAUDE report 50320872 ↗MalfunctionAug 3, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50113813 ↗InjuryJul 27, 2026Device-Device Incompatibility
It was reported on (b)(6) 2026 that HCP chose a 10/200mm 125 degree TFNA implant to treat patient. With proper technique, the TFNA was inserted into the patient and the next step to put the lag screw in proceeded. Guidewire and step reamer passed through the tfna implant appropriately but when it was time to put the lag screw implant in, the lag screw stop advancing and metal grinding noises were heard. Lag screw was removed and inserted again with the same result. After removing the now damaged lag screw, the instrumentation was checked over and it was confirmed that everything was properly assembled and nothing came loose throughout the course of the procedure. A new lag screw was chose and insertion was attempted again. This time the lag screw threads became stuck inside the TFNA and time was spent disengaging the the two implants with much difficulty and some damage to the lag screw instrumentation.A third new lag screw was chosen and insertion was attempted free handed in case the cannula became fault but failed as well. We removed al implants and instruments and a new TFNA implant was chosen assembled. From there, all instrumentation worked properly and the procedure was comp
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50034565 ↗MalfunctionJun 22, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THERE WAS A CUT-THROUGH OF THE HELIX BLADE, WITH BROKEN SET SCREW OF THE TFNA. THE PATIENT UNDERWENT REVISION SURGERY. IMPLANTS WERE DESTROYED BY THE FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25578627 ↗InjuryJun 11, 2026Migration
IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT ORIF SURGERY FOR FEMORAL FRACTURE WITH THE PRODUCT IN QUESTION. AFTER SURGERY, IT WAS OBSERVED THAT THE POSITION OF THE BLADE HAD SHIFTED APPROXIMATELY 20MM. THE BLADE WAS REMOVED ON (B)(6) 2026. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 25471247 ↗InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY VIA TFNA AGMT AT ANOTHER HOSPITAL IN (B)(6) 2025 WITH THE IMPLANTS IN QUESTION. ON (B)(6) 2026, THE AGENCY CONTACTED TO REPORT A FRACTURE OCCURRED UNDER THE NAIL IN QUESTION. THE RE-OPERATION WITH CABLES AND PLATE IS SCHEDULED ON (B)(6) 2025, TO REMOVE ONLY THE TRANSVERSE RETAINING SCREW. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Bone Fracture(s)
MAUDE report 25456307 ↗MalfunctionMay 26, 2026No Apparent Adverse Event
IT WAS REPORTED THAT ON (B)(6), 2026, CONNECTING SCREW FOR 125° TFNA AIMING ARM CRACKED WHILE INSERTING A NAIL. THIS CAUSED THE GUIDE TO BECOME LOOSE, SUBSEQUENTLY CAUSING THE GUIDE WIRE TO MISS THE NAIL. WHEN REAMING FOR A LAG SCREW, THE NAIL WAS DAMAGED DUE TO THE MISS PLACED GUIDE WIRE. THE NAIL HAD TO BE REMOVED AND REPLACED WITH A NEW ONE TO FINISH THE PROCEDURE. THERE WAS 30 MINUTES SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25276079 ↗MalfunctionMay 12, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE TFNA FEM NAIL Ø10 130° L170 TIMO15 EXPERIENCED AN ISSUE WITH THE LOCKING MECHANISM BEING ENGAGED PRIOR TO SHIPPING. THE EVENT RESULTED IN A SIGNIFICANT SURGICAL DELAY OF 30 MINUTES, BUT THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT, AND NO PATIENT INVOLVEMENT OR OBSERVABLE CLINICAL SYMPTOMS WERE IDENTIFIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25148203 ↗MalfunctionApr 14, 2026Material Discolored; Material Deformation
IT WAS REPORTED THAT THERE WAS A BOX DAMAGED ON TFNA NAILS, AND OTHER INSTRUMENTS NEED REPLACEMENT. ITEMS WERE BENT AND THERE WERE FADED HANDLES. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24871268 ↗
Other Synthes GmbH products
All Synthes GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page