NA 04.005.532SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982086013), received between May 25, 2018 and Mar 31, 2022 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL PROCEDURE ON (B)(6) 2020 DUE TO NONUNION. THE PRIMARY SURGERY WAS DONE ON (B)(6) 2020, TO TREAT TIBIAL FRACTURE DUE TO A TRAFFIC ACCIDENT. THE IMPLANTS WERE REMOVED WITH THE REGULAR TEST BUT WITHOUT CULTURES. THE SURGERY WAS SUCCESSFUL. THE PATIENT STATUS IS STABLE AND WAS DISCHARGED ON (B)(6) 2020, AND THE LAST CLINIC FOLLOW-UP WAS ON (B)(6) 2021, WITH SATISFACTORY HEALING. THIS REPORT IS FOR ONE (1) UNKNOWN NAIL LOCKING SCREW THIS IS REPORT 5 OF 6 FOR COMPLAINT PC-(B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13970637 ↗
• InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL PROCEDURE ON (B)(6) 2020 DUE TO NONUNION. THE PRIMARY SURGERY WAS DONE ON (B)(6) 2020, TO TREAT TIBIAL FRACTURE DUE TO A TRAFFIC ACCIDENT. THE IMPLANTS WERE REMOVED WITH THE REGULAR TEST BUT WITHOUT CULTURES. THE SURGERY WAS SUCCESSFUL. THE PATIENT STATUS IS STABLE AND WAS DISCHARGED ON (B)(6) 2020, AND THE LAST CLINIC FOLLOW-UP WAS ON (B)(6) 2021, WITH SATISFACTORY HEALING. THIS REPORT IS FOR (1) UNKNOWN NAIL LOCKING SCREW. THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13970631 ↗
• InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL PROCEDURE ON (B)(6) 2020 DUE TO NONUNION. THE PRIMARY SURGERY WAS DONE ON (B)(6) 2020, TO TREAT TIBIAL FRACTURE DUE TO A TRAFFIC ACCIDENT. THE IMPLANTS WERE REMOVED WITH THE REGULAR TEST BUT WITHOUT CULTURES. THE SURGERY WAS SUCCESSFUL. THE PATIENT STATUS IS STABLE AND WAS DISCHARGED ON (B)(6) 2020, AND THE LAST CLINIC FOLLOW-UP WAS ON (B)(6) 2021, WITH SATISFACTORY HEALING. THIS REPORT IS FOR (1) UNKNOWN NAIL LOCKING SCREW. THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13970629 ↗
• MalfunctionJul 28, 2021Break; Break

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE: (B)(6). PATIENT¿S WEIGHT RANGE: (B)(6). GENDER: 0 FEMALE, 1 MALE, AND 0 UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 12240851 ↗
• InjuryJul 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED IN (B)(6) 2017, THE PATIENT UNDERWENT THE SURGERY BY USING A COMPETITORS FEMORAL IMPLANT SYSTEM IN ORDER TO PREVENT BONE FRACTURES DUE TO THE BREAST CANCER BEING SPREAD TO THE FEMUR. ON (B)(6) 2020, A REVISION SURGERY WAS PERFORMED TO REPLACE THE FEMORAL IMPLANTS DUE TO DEVICE BREAKAGE WITH SYNTHES TROCHANTERIC FIXATION NAIL ANTIROTATION (TFNA) LONG IMPLANTS. ON (B)(6) 2020, A REVISION SURGERY WAS PERFORMED DUE TO THE BREAKAGE OF THE TFNA LONG IMPLANTS. THE PATIENT WAS REVISED TO ANOTHER SET OF IMPLANTS. THERE WAS A ONE (1) HOUR SURGICAL DELAY DUE TO EXTENDED TIME IN REMOVING THE BROKEN DEVICE. IT WAS FURTHER REPORTED THE PATIENT ALSO HAD A NON-UNION WHICH MAY HAVE CONTRIBUTED TO THE DEVICE BREAKAGE. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Impaired Healing; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10343578 ↗
• MalfunctionMar 27, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN ORTHOPEDIC PROCEDURE, THE SURGEON EXPERIENCED COMPLICATIONS WHILE USING THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA) DEVICES. DIFFICULTIES WERE ENCOUNTERED WHILE USING THE STEPPED DRILL BIT IN PREPARATION FOR THE HELICAL BLADE. AFTER DRILLING, THE SURGEON PROCEEDED TO INSERT THE HELICAL BLADE COMPONENT, WHICH WAS DIFFICULT TO INSERT. THE SURGEON PROCEEDED TO INSERT THE DISTAL LOCKING SCREW AND HAD COMPLICATIONS WITH INSERTING IT. AFTERWARDS THE SURGEON NOTICED THAT AN INCORRECT AIMING ARM (125 DEGREE) WAS UTILIZED. THE TFNA NAIL THAT WAS IMPLANTED WAS A 130 DEGREE NAIL. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND SURGICAL OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: TFNA NAIL (PART 04.037.142S, LOT UNKNOWN, QUANTITY 1), CANNULATED STEPPED DRILL BIT (PART 03.037.022, LOT UNKNOWN, QUANTITY 1), THREE-FLUTED DRILL BIT (PART 03.010.061, LOT UNKNOWN, QUANTITY 1), TFNA FENESTRATED HELICAL BLADE 100MM - STERILE(PART PART # 04.038.400S, LOT UNKNOWN, QUANTITY 1), GUIDES/SLEEVES/AIMING: AIMING ARM (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM F/IM NAIL-

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9889254 ↗
• InjuryFeb 4, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT WAS IMPLANTED WITH A TFNA NAIL, FENESTRATED HELICAL BLADE AND DISTAL LOCKING SCREW FOR A REVERSE OBLIQUE TYPE INTERTROCHANTERIC FRACTURE. POST-OPERATIVE, ON (B)(6) 2019, PATIENT WAS PRESENTED TO THE SURGEON WITH NEW ONSET OF HIP PAIN. THE SURGEON REVIEWS THE X-RAYS AND OBSERVED A NON-UNION OF THE FRACTURE AS WELL AS A BROKEN TFNA AND DISTAL LOCKING SCREW. ON (B)(6) 2019, PATIENT UNDERWENT BONE GRAFTING, REVISION IM NAILING AND HARDWARE REMOVAL OF A BROKEN TROCHANTERIC FEMORAL NAIL ADVANCE (TFNA) AND DISTAL LOCKING SCREW. ALL BROKEN AND INTACT HARDWARE WERE REMOVED. A NEW TFNA, FENESTRATED HELICAL BLADE, TRAUMACEM AND TWO (2) LOCKING SCREWS WERE IMPLANTED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: FENESTRATED HELICAL BLADE (PART 04.038.395S, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) DISTAL LOCKING SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8302552 ↗
• InjuryJul 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT IMPLANT PROCEDURE. PATIENT WAS IMPLANTED WITH ONE (1) UNKNOWN NAIL, ONE (1) 5MM TITANIUM LOCKING SCREW 42MM AND ONE (1) 5MM TITANIUM LOCKING SCREW 56MM. POST-OPERATIVE ON (B)(6) 2018, PATIENT UNDERWENT ROTATIONAL OSTEOTOMY OF THE FEMUR DUE TO BONE NOT HAVING HEALED AND THE ALIGNMENT BEING OFF. DURING THE SURGERY, SURGEON REMOVED TWO SCREWS AND IMPLANTED TWO NEW SCREWS BACK IN THE NAIL. THE SCREWS WERE REMOVED INTACT, WITHOUT DIFFICULTY, THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS NOT REPORTED. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM F/IM NAIL-STER. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 7719680 ↗
• InjuryMay 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018, TO REMOVE FIVE (5) TITANIUM LOCKING SCREWS, AN 11MM TITANIUM CANNULATED TIBIAL NAIL AND A TITANIUM END CAP DUE TO DELAYED HEALING AND A NON-UNION. IT ORIGINAL IMPLANT DATE OF THE EXPLANTED DEVICES IS UNKNOWN AT THIS TIME. THE PATIENT WAS REVISED TO A LARGER 13MM TIBIAL NAIL AND USED A LOCKING SCREW ON THE LATERAL SIDE TO AID WITH PROPER REDUCTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAYS AND NO ADDITIONAL MEDICAL INTERVENTION REQUIRED DURING THE PROCEDURE. NO PATIENT OUTCOME REPORTED. THIS IS REPORT 7 OF 7 FOR (B)(4).

  Patient problems: Impaired Healing; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7546769 ↗
• InjuryMay 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018, TO REMOVE FIVE (5) TITANIUM LOCKING SCREWS, AN 11MM TITANIUM CANNULATED TIBIAL NAIL AND A TITANIUM END CAP DUE TO DELAYED HEALING AND A NON-UNION. IT ORIGINAL IMPLANT DATE OF THE EXPLANTED DEVICES IS UNKNOWN AT THIS TIME. THE PATIENT WAS REVISED TO A LARGER 13MM TIBIAL NAIL AND USED A LOCKING SCREW ON THE LATERAL SIDE TO AID WITH PROPER REDUCTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAYS AND NO ADDITIONAL MEDICAL INTERVENTION REQUIRED DURING THE PROCEDURE. NO PATIENT OUTCOME REPORTED. THIS IS REPORT 4 OF 7 FOR (B)(4).

  Patient problems: Impaired Healing; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7546284 ↗