NA 03.037.112Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886982070562), received between Mar 12, 2018 and Jul 30, 2025 — classified as 3 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (14 reports).

9 other recalls cover devices cleared under the same FDA submission (K131548); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2025Break; Break

  IT WAS REPORTED THAT REP HAS 4 SCREWDRIVERS THAT ARE NOT RETAINING TO THE SCREWDRIVER SHAFTS. THE SCREWS ARE FALLING OFF THE SCREWDRIVER SHAFT AND THEY'RE NOT HOLDING WELL AT ALL. ADDITIONALLY, AIMING ARMS AND 2 INSERTION HANDLES ARE BROKEN. ALL MALFUNCTIONS OCCURRED POST-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22663614 ↗
• MalfunctionJul 30, 2025Break; Break

  IT WAS REPORTED THAT REP HAS 4 SCREWDRIVERS THAT ARE NOT RETAINING TO THE SCREWDRIVER SHAFTS. THE SCREWS ARE FALLING OFF THE SCREWDRIVER SHAFT AND THEY'RE NOT HOLDING WELL AT ALL. ADDITIONALLY, AIMING ARMS AND 2 INSERTION HANDLES ARE BROKEN. ALL MALFUNCTIONS OCCURRED POST-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22662807 ↗
• MalfunctionApr 28, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ANTI ROTATION PINS HIT THE NAIL, THE OPENING REAMER FOR LAG SCREW HIT THE NAIL, AND REAMED PART OF NAIL. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES. ORIGINAL COMPLAINT IN (B)(4) INVOLVES 27 PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919238 ↗
• MalfunctionApr 28, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ANTI ROTATION PINS HIT THE NAIL, THE OPENING REAMER FOR LAG SCREW HIT THE NAIL, AND REAMED PART OF NAIL. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES. ORIGINAL COMPLAINT IN (B)(4) INVOLVES 27 PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919219 ↗
• MalfunctionApr 28, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ANTI ROTATION PINS HIT THE NAIL, THE OPENING REAMER FOR LAG SCREW HIT THE NAIL, AND REAMED PART OF NAIL. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919171 ↗
• MalfunctionMay 10, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024 THE PERCUTANEOUS HANDLE FOR TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) APPEARS TO BE STRIPPED AND THE SURGEONS HAVE BEEN HAVING TROUBLE DIS-ENGAGING THE NAIL FROM THE HANDLE AT THE END OF THE CASE. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS TWENTY MINUTES OF SURGICAL DELAY. THERE WAS NO PATIENT HARM. THIS REPORT IS FOR A PERCUTANEOUS RADIOLUCENT INSERTION HANDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19286283 ↗
• MalfunctionMay 10, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON APRIL 15, 2024 THE PERCUTANEOUS HANDLE FOR TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) APPEARS TO BE STRIPPED AND THE SURGEONS HAVE BEEN HAVING TROUBLE DIS-ENGAGING THE NAIL FROM THE HANDLE AT THE END OF THE CASE. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS TWENTY MINUTES OF SURGICAL DELAY. THERE WAS NO PATIENT HARM. THIS REPORT IS FOR A PERCUTANEOUS RADIOLUCENT INSERTION HANDLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19286207 ↗
• MalfunctionMar 19, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A REMOVAL OF THE INSERTION HANDLE FROM A TFNA, IT WAS INCREDIBLY DIFFICULT TO DISENGAGE THE CANNULATED CONNECTING SCREW FROM THE PERCUTANEOUS INSERTION HANDLE. MULTIPLE SURGEONS ATTEMPTED TO LOOSEN THE CONNECTION AND IT TOOK MORE TIME AND EFFORT THAN IT SHOULD. DIFFERENT METHODS WERE USED FOR REMOVAL AND THE ENTIRE PROCESS, WHICH TOOK MORE THAN TEN(10) MINUTES. TOTAL OF FOUR(4) COMPLETE SETS ARE KEPT AT THIS ACCOUNT AND IT WAS UNKNOWN WHICH SET WAS USED IN THIS CASE SO ALL CONNECTING SCREWS AND PERCUTANEOUS INSERTION HANDLES WILL BE REPLACED AND CURRENT ONES ARE RETURNED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF TEN(10) MINUTES. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) CANNULATED CONNECTING SCREW. THIS IS REPORT 10 OF 11 FOR COMPLAINT (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13825593 ↗
• MalfunctionMar 19, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A REMOVAL OF THE INSERTION HANDLE FROM A TFNA, IT WAS INCREDIBLY DIFFICULT TO DISENGAGE THE CANNULATED CONNECTING SCREW FROM THE PERCUTANEOUS INSERTION HANDLE. MULTIPLE SURGEONS ATTEMPTED TO LOOSEN THE CONNECTION AND IT TOOK MORE TIME AND EFFORT THAN IT SHOULD. DIFFERENT METHODS WERE USED FOR REMOVAL AND THE ENTIRE PROCESS, WHICH TOOK MORE THAN TEN(10) MINUTES. TOTAL OF FOUR(4) COMPLETE SETS ARE KEPT AT THIS ACCOUNT AND IT WAS UNKNOWN WHICH SET WAS USED IN THIS CASE SO ALL CONNECTING SCREWS AND PERCUTANEOUS INSERTION HANDLES WILL BE REPLACED AND CURRENT ONES ARE RETURNED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF TEN(10) MINUTES. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) CANNULATED CONNECTING SCREW. THIS IS REPORT 9 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13825589 ↗
• MalfunctionMar 19, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A REMOVAL OF THE INSERTION HANDLE FROM A TFNA, IT WAS INCREDIBLY DIFFICULT TO DISENGAGE THE CANNULATED CONNECTING SCREW FROM THE PERCUTANEOUS INSERTION HANDLE. MULTIPLE SURGEONS ATTEMPTED TO LOOSEN THE CONNECTION AND IT TOOK MORE TIME AND EFFORT THAN IT SHOULD. DIFFERENT METHODS WERE USED FOR REMOVAL AND THE ENTIRE PROCESS, WHICH TOOK MORE THAN TEN(10) MINUTES. TOTAL OF FOUR(4) COMPLETE SETS ARE KEPT AT THIS ACCOUNT AND IT WAS UNKNOWN WHICH SET WAS USED IN THIS CASE SO ALL CONNECTING SCREWS AND PERCUTANEOUS INSERTION HANDLES WILL BE REPLACED AND CURRENT ONES ARE RETURNED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF TEN(10) MINUTES. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) CANNULATED CONNECTING SCREW. THIS IS REPORT 11 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13825364 ↗
• MalfunctionMar 19, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A REMOVAL OF THE INSERTION HANDLE FROM A TFNA, IT WAS INCREDIBLY DIFFICULT TO DISENGAGE THE CANNULATED CONNECTING SCREW FROM THE PERCUTANEOUS INSERTION HANDLE. MULTIPLE SURGEONS ATTEMPTED TO LOOSEN THE CONNECTION AND IT TOOK MORE TIME AND EFFORT THAN IT SHOULD. DIFFERENT METHODS WERE USED FOR REMOVAL AND THE ENTIRE PROCESS, WHICH TOOK MORE THAN TEN(10) MINUTES. TOTAL OF FOUR(4) COMPLETE SETS ARE KEPT AT THIS ACCOUNT AND IT WAS UNKNOWN WHICH SET WAS USED IN THIS CASE SO ALL CONNECTING SCREWS AND PERCUTANEOUS INSERTION HANDLES WILL BE REPLACED AND CURRENT ONES ARE RETURNED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF TEN(10) MINUTES. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) CANNULATED CONNECTING SCREW. THIS IS REPORT 2 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13824266 ↗
• MalfunctionJan 26, 2021Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE, THE INSERTION HANDLE AND TWO (2) 5MM FLEXIBLE SCREWDRIVER BROKE. THE 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE WAS STRIPPED AND UNABLE TO BE LOCKED WITH THE COUPLING SCREW. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME WAS NOT REPORTED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) PERCUTANEOUS RADIOLUCENT INSERTION HANDLE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11229693 ↗
• InjuryJun 4, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON INSERTED A PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL USING THE PERCUTANEOUS RADIOLUCENT HANDLE. AFTER THE NAIL WAS INSERTED, LAG SCREW INSERTED, AND DISTAL LOCKING SCREW INSERTED, THE SURGEON ATTEMPTED TO REMOVE THE HANDLE USING THE T-HANDLE BALL HEX 8 MM SCREWDRIVER. THE END OF THE SCREWDRIVER BROKE OFF AT THE TOP OF THE CONNECTING SCREW. AFTER ATTEMPTING TO REMOVE THE BROKEN END OF THE SCREWDRIVER, IT WAS DETERMINED THAT IT COULD NOT BE REMOVED WHICH PROHIBITED THE HANDLE FROM BEING REMOVED FROM THE NAIL. THE SURGEON DETERMINED THAT THE BEST COURSE OF ACTION WOULD BE TO CUT THE PERCUTANEOUS RADIOLUCENT HANDLE CLOSE TO THE CONNECTION TO THE NAIL TO GAIN BETTER ACCESS AND POTENTIALLY BE ABLE TO REMOVE THE SCREWDRIVER TIP THAT BROKE OFF IN THE CONNECTING SCREW. THE HOPE WAS THAT IF THE BROKEN PIECE COULD BE REMOVED THEN THE HANDLE COULD BE REMOVED. AFTER CUTTING THE HANDLE IT WAS DETERMINED THAT THE PIECE COULD STILL NOT BE REMOVED AND THAT THE END OF THE HANDLE, BROKEN SCREWDRIVER PIECE AND CONNECTING SCREW WOULD HAVE TO BE LEFT IN THE PATIENT. ACTION TAKEN WHEN THE EVENT OCCURRED MULTIPLE OPTIONS WERE EXPLORED AND CONSIDERED. THRE

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 10120280 ↗
• MalfunctionSep 5, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, AFTER AN UNKNOWN PROCEDURE, THREE (3) PERCUTANEOUS RADIOLUCENT INSERTION HANDLE FOR TROCHANTERIC FEMORAL NAILING ADVANCED (TFNA) WERE DIFFICULT TO REMOVE FROM AN UNKNOWN NAIL AT THE END OF THE OPERATION. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO PATIENT CONSEQUENCE. THIS IS REPORT 3 FOR 4 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8964393 ↗
• MalfunctionSep 5, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, AFTER AN UNKNOWN PROCEDURE, THREE (3) PERCUTANEOUS RADIOLUCENT INSERTION HANDLE FOR TROCHANTERIC FEMORAL NAILING ADVANCED (TFNA) WERE DIFFICULT TO REMOVE FROM AN UNKNOWN NAIL AT THE END OF THE OPERATION. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO PATIENT CONSEQUENCE. THIS IS REPORT 2 FOR 4 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8964383 ↗
• MalfunctionSep 5, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, AFTER AN UNKNOWN PROCEDURE, THREE (3) PERCUTANEOUS RADIOLUCENT INSERTION HANDLE FOR TROCHANTERIC FEMORAL NAILING ADVANCED (TFNA) WERE DIFFICULT TO REMOVE FROM AN UNKNOWN NAIL AT THE END OF THE OPERATION. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO PATIENT CONSEQUENCE. THIS IS REPORT 1 FOR 4 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8964375 ↗
• MalfunctionOct 30, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON OCTOBER 04, 2018, THE EVENT OCCURRED DURING A TROCHANTERIC FEMORAL NAILING SYSTEM ADVANCED (TFNA) PROCEDURE FOR A FEMURE FRACTURE. THE SURGEON HAD NO ISSUE WHEN INSERTING THE TFNA AND LAG SCREW INTO THE PATIENT. BUT, WHEN THE SURGEON REMOVED THE AIMING ARM FROM THE PERCUTANEOUS HANDLE, IT SOUNDED LIKE IT CROSS THREADED INTO THE PROXIMAL WHICH MADE IT DIFFICULT TO REMOVE. THE SURGEON ENDED UP DISCONNECTING THE AIMING ARM, BUT THE CONNECTING SCREW BECAME TEMPORARILY STUCK TO THE NAIL AND THEN EVENTUALLY REMOVED. THERE WAS A SURGICAL DELAY OF 5 MINUTES DUE TO ATTEMPTS IN REMOVING THE HANDLE. THERE WERE NO FURTHER ISSUES OR COMPLICATIONS IN THE PROCEDURE. PATIENT OUTCOME WAS REPORTED AS GOOD. CONCOMITANT DEVICES REPORTED: TFNA LAG SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8019181 ↗
• MalfunctionJul 27, 2018Break; Break

  (B)(4) REPORTS THAT DURING A TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) PROCEDURE ON (B)(6) 2018, THE PERCUTANEOUS HANDLE BROKE DURING NAIL INSERTION. THERE WAS NO HARM TO THE PATIENT AND NO PATIENT CONSEQUENCE. THERE WAS A FIVE-MINUTE SURGICAL DELAY. CONCOMITANT DEVICE: TFNA NAIL (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A PERCUTANEOUS RADIOLUCENT INSERTION HANDLE. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7726073 ↗
• InjuryJun 1, 2018Disassembly; Disassembly

  IT WAS REPORTED THAT ON (B)(6) 2018, A PATIENT UNDERWENT A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) PROCEDURE. DURING THE SURGERY, THE SURGEON TRIED TO TAKE OFF THE PERCUTANEOUS RADIOLUCENT INSERTION HANDLE AFTER HAVING PLACED AND LOCKED DOWN THE TFNA FEMORAL NAIL, TITANIUM ALLOY AND LAG SCREW. HOWEVER, THE CONNECTING SCREW FOR INSERTION HANDLE WOULD NOT RELEASE FROM THE NAIL. THE PATIENT¿S LEG WAS ABDUCTED AND THE CONNECTING SCREW COULD NOT BE REMOVED. THE SURGEON THEN REMOVED THE INSTRUMENTATION AND IMPLANTS. A NEW SECOND NAIL OF THE SAME PART AND DIFFERENT SIZED LAG SCREW WERE INSERTED, AND ANOTHER NEW SECOND CONNECTING SCREW AND INSERTION HANDLE WERE USED. THE SAME ISSUE OCCURRED. THE CONNECTING SCREW BECAME STUCK TO THE NAIL WHILE TAKING OFF THE SECOND INSERTION HANDLE. THE SURGEON WAS ABLE TO DISENGAGE THE CONNECTING SCREW FROM THE NAIL. THE SECOND NAIL AND LAG SCREW REMAINED IMPLANTED IN THE PATIENT. IT WAS NOTED THAT THE NAIL WAS NOT FITTING ON PROPERLY, AND THAT THE TIPS OF BOTH INSERTION HANDLES HAD BECOME BENT OR TORQUED. IT WAS ALSO NOTED THAT THE SCREW INSERTER BENT AT THE HANDLE AND THE HELICAL BLADE/SCREW COUPLING SCREW BENT AT THE TIP OF THE THREADS. THERE WAS AN

  Patient problems: No Code Available

  MAUDE report 7561408 ↗
• InjuryJun 1, 2018Disassembly; Disassembly

  IT WAS REPORTED THAT ON (B)(6) 2018, A PATIENT UNDERWENT A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) PROCEDURE. DURING THE SURGERY, THE SURGEON TRIED TO TAKE OFF THE PERCUTANEOUS RADIOLUCENT INSERTION HANDLE AFTER HAVING PLACED AND LOCKED DOWN THE TFNA FEMORAL NAIL, TITANIUM ALLOY AND LAG SCREW. HOWEVER, THE CONNECTING SCREW FOR INSERTION HANDLE WOULD NOT RELEASE FROM THE NAIL. THE PATIENT¿S LEG WAS ABDUCTED AND THE CONNECTING SCREW COULD NOT BE REMOVED. THE SURGEON THEN REMOVED THE INSTRUMENTATION AND IMPLANTS. A NEW SECOND NAIL OF THE SAME PART AND DIFFERENT SIZED LAG SCREW WERE INSERTED, AND ANOTHER NEW SECOND CONNECTING SCREW AND INSERTION HANDLE WERE USED. THE SAME ISSUE OCCURRED. THE CONNECTING SCREW BECAME STUCK TO THE NAIL WHILE TAKING OFF THE SECOND INSERTION HANDLE. THE SURGEON WAS ABLE TO DISENGAGE THE CONNECTING SCREW FROM THE NAIL. THE SECOND NAIL AND LAG SCREW REMAINED IMPLANTED IN THE PATIENT. IT WAS NOTED THAT THE NAIL WAS NOT FITTING ON PROPERLY, AND THAT THE TIPS OF BOTH INSERTION HANDLES HAD BECOME BENT OR TORQUED. IT WAS ALSO NOTED THAT THE SCREW INSERTER BENT AT THE HANDLE AND THE HELICAL BLADE/SCREW COUPLING SCREW BENT AT THE TIP OF THE THREADS. THERE WAS AN

  Patient problems: No Code Available

  MAUDE report 7561349 ↗
• MalfunctionMar 12, 2018Failure To Adhere Or Bond; Material Distortion; Failure To Adhere Or Bond; Material Distortion

  IT WAS REPORTED THAT DURING A PROCEDURE FOR HIP FRACTURE ON (B)(6) 2018, A PERCUTANEOUS RADIOLUCENT INSERTION HANDLE WOULD NOT GET CONNECTED WITH A TI CANNULATED TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) NAIL. AS THE SURGEON WAS STRUGGLING TO GET THE NAIL CONNECTED TO THE HANDLE, THE NAIL DROPPED ON THE GROUND (NAIL WAS INTACT). ANOTHER TFNA NAIL WAS AVAILABLE FOR COMPLETION OF THE SURGERY. AS THE PERCUTANEOUS RADIOLUCENT INSERTION HANDLE WAS NOT FUNCTIONING CORRECTLY, A STANDARD INSERTION HANDLE WAS USED IN PLACE OF THE PERCUTANEOUS RADIOLUCENT INSERTION HANDLE AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. THE PATIENT WAS STABLE AFTER THE SURGERY. DURING MANUFACTURE¿S INVESTIGATION OF THE RETURNED SUBJECT DEVICE, IT WAS IDENTIFIED THAT THE INSERTION HANDLE WAS RECEIVED INTACT BUT WITH DEFORMATION OF EDGES WHICH CONNECT WITH THE MATING NAIL. THE DEFORMATION HAS RESULTED IN RAISED EDGES AT THE TWO SLOTTED OPENINGS AND OUTWARD FLARING OF THE ENDS. THE TAB COMPONENT ALSO SHOWED AN AREA OF SCRAPING AND RAISED EDGES ON THE FLATS. THIS CONDITION WAS RE-EVALUATED AND DETERMINED TO BE REPORTABLE ON MARCH 12, 2018. CONCOMITANT DEVICES REPORTED: 12MM/130 DEG TI CANN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7332431 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131548. One submission often covers many models, so check the product and lot details in each record.

• Z-1239-2024 · Jan 24, 2024 · Open, Classified
  TFNA Femoral Nail 9mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S
• Z-1240-2024 · Jan 24, 2024 · Open, Classified
  TFNA Femoral Nail 11mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144S
• Z-1247-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.212S
• Z-1246-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S
• Z-1248-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number: 04.037.242S
• Z-0126-2016 · Sep 21, 2015 · Terminated
  Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head eleme
• Z-2091-2015 · Jun 10, 2015 · Terminated
  Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element
• Z-1600-2015 · Apr 9, 2015 · Terminated
  TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
• Z-1352-2015 · Feb 24, 2015 · Terminated
  Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proxima