NA 04.005.536SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982086051), received between May 25, 2018 and Dec 20, 2023 — classified as 5 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE MUE (MÜNSTER, GERMANY) REPORTED AN ADVERSE EVENT IN OUR DATABASE WHICH IS CONSIDERED (POSSIBLY) RELATED TO THE DEVICE. SUBJECT (B)(6). IT WAS REPORTED A HIGH ENERGY TRAUMA ACCIDENT OCCURRED ON (B)(6) 2023 RESULTING IN AN OPEN RIGHT TIBIAL FRACTURE. IT WAS LISTED AS A TYPE IIIC: OPEN FRACTURE ASSOCIATED WITH ARTERIAL INJURY REQUIRING REPAIR. A RIGHT FIBULA WAS ALSO SUSTAINED. SURGERY INCLUDING ARTERY REPAIR WITH DEBRIDEMENT AND EXTERNAL FIXATION OCCURRED ON (B)(6) 2023. WOUND REVISION ONLY OCCURRED ON (B)(6) 2023 AND (B)(6) 2023; DEBRIDEMENT AND ANTIBIOTICS ADMINISTERED. ON (B)(6) 2023, A TIBIAL NAIL AND 1 PROXIMAL SCREW AND 4 DISTAL SCREWS WERE IMPLANTED. ON (B)(6) 2023 INFECTION AND NECROSIS WITH ABSCESS LOWER LEG LAT. RIGHT WAS NOTED. ON (B)(6) 2023, EXTENSIVE DEBRIDEMENT AND NECROSECTOMY WITH A PARTIAL RESECTION OF FIBULA OCCURRED. ON (B)(6) 2023, IMPLANTS WERE REMOVED AND RIGHT LOWER LEG AMPUTATION OCCURRED. PATIENT RECOVERED WITH PERSISTENT DAMAGE. THIS REPORT IS FOR ONE (1) PROXIMAL LOCKING SCREW. THIS IS REPORT 2 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Abscess; Necrosis; Unspecified Infection

  MAUDE report 18370000 ↗
• InjurySep 14, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022 SURGEON REMOVED HELICAL BLADE DUE TO BACKING OUT AND REPLACED WITH TINA SCREW. DISTAL SCREWS ALSO BROKEN. THERE WAS NO SURGERY DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) 5.0 TI LCKNG SCREW T25 SD 46 F/IM NAIL-S THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15422121 ↗
• InjuryJul 7, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE REMOVAL OF BROKEN NAIL DUE TO NONUNION. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO FRAGMENTS WERE GENERATED. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1) 5.0 TI LCKNG SCREW T25 SD 46 F/IM NAIL-S. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 14950180 ↗
• InjuryOct 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT RE-OPERATION DUE TO BEING NON-COMPLIANT WITH THE PHYSICIAN'S INSTRUCTIONS WHICH RESULTED IN A NON-UNION FRACTURE. TITANIUM CANNULATED TIBIAL NAIL AND (4) LOCKING SCREWS WILL BE REMOVED. THERE WAS PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 46MM F/IM NAIL-STER. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12666369 ↗
• 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 6 OF 7 FOR (B)(4).

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

  MAUDE report 7546596 ↗