NA 03.010.095Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982067654), received between Mar 20, 2017 and Apr 6, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K040762); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON AN UNSPECIFIED DATE, THE SCREW WAS COLD WELDED AND COULD NOT BE REMOVED. THIS REPORT IS FOR ONE (1) CONNECSCR CANN SHORT F/TIBNAIL F/03.010. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14022638 ↗
• MalfunctionOct 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING A TIBIA OSTEOSYNTHESIS SURGERY, THERE WAS A MISALIGNMENT OF THE PROXIMAL LOCKING OF AN UNKNOWN EXPERT TIBIAL NAIL WITH THE CONNECTING SCREW. THE INSERTION HANDLE AND AIMING ARM WERE UNABLE TO DISASSEMBLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) CONNECSCR CANN SHORT F/TIBNAIL F/03.010. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12705570 ↗
• MalfunctionDec 15, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, THE CONNECTING SCREW BROKE IN THE NAIL. THE SCREW BROKE BETWEEN THE AIMING JIG AND THE EXPERT TIBIAL NAIL. THE SCREW BROKE WHEN THE PATIENT¿S LEG WAS FULLY EXTENDED FOR DISTAL LOCKING. THE SCREW WAS REMOVED EASILY BY USING AN ¿EASY OUT¿ DRILL TO REAM INTO THE CONNECTION SCREW. ANOTHER CONNECTING SCREW WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: NAIL (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), AIMING JIG (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) CANNULATED CONNECTING SCREW FOR TIBIA INSERTION HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11013712 ↗
• MalfunctionMar 20, 2017Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THERE WERE DIFFICULTIES DISENGAGING THE CANNULATED CONNECTING SCREWS FROM THE INSERTION HANDLES TWICE. PATIENT UNDERWENT A TIBIA NAIL PROCEDURE ON (B)(6) 2017 FOR A TIBIA SHAFT FRACTURE. THE PROCEDURE STARTED ON THE NIGHT OF (B)(6) 2017 AND CARRIED INTO (B)(6) 2017. THE FRACTURE WAS REDUCED. USING THE AIMING CONSTRUCT WHICH CONSISTED OF AN AIMING ARM, INSERTION HANDLE, AND CONNECTING SCREW, A 9MM TITANIUM (TI) CANNULATED TIBIAL NAIL AND TWO PROXIMAL 4.0MM TI LOCKING SCREWS WERE IMPLANTED. UPON ATTEMPTING TO REMOVE THE AIMING CONSTRUCT, THE CONNECTING SCREW WOULD NOT LOOSEN FROM THE INSERTION HANDLE. THE RESIDENT ATTEMPTED TO WIGGLE THE NAIL TO LOOSEN IT WHILE THE PROXIMAL LOCKING SCREWS WERE STILL IMPLANTED AND WAS UNSUCCESSFUL. SUBSEQUENTLY, THE PROXIMAL LOCKING SCREWS AND NAIL HAD TO BE COMPLETELY REMOVED. AFTER REMOVAL, IT WAS NOTED THAT THE PROXIMAL END OF THE NAIL WAS BENT. SURGERY PROCEEDED BY USING A NEW AIMING CONSTRUCT THAT WAS AVAILABLE IN THE SET. A NEW NAIL AND ONE OF THE LOCKING SCREWS USED DURING THE FIRST ATTEMPT WAS REUSED. AFTER REMEASURING AND REDRILLING THE HOLE DURING THE SECOND ATTEMPT, IT WAS DETERMINED THAT THE SIZE OF THE OTHER LOCKING S

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6417340 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040762. One submission often covers many models, so check the product and lot details in each record.

• Z-2051-2015 · Jun 3, 2015 · Terminated
  TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal
• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.