NA 03.010.440Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 10886982068828), received between Feb 22, 2017 and Sep 2, 2026 — classified as 4 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (37 reports).

1 other recall cover devices cleared under the same FDA submission (K111667); 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 25 most recent of 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50571432 ↗
• MalfunctionJan 9, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE CONNECTING SCREW WAS HARD TO DISENGAGE FROM THE INSERTION HANDLE INTRA-OPERATIVELY. THE T-HANDLE BALL HEX SCREWDRIVER WAS SKIPPING INSIDE THE CONNECTING SCREW. IT WAS VERY HARD TO DISENGAGE. THE SCREWDRIVER MIGHT BE WORN. THE CONNECTING SCREW WAS CHANGED. THERE WAS NO PATIENT HARM, NO ADVERSE EFFECTS AND NO DELAY TO THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21117774 ↗
• MalfunctionMay 20, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, IT WAS IDENTIFIED THAT SUPRAPATELLAR TN INSERTION ARCH HAS A DENT. WHEN IT IS COUPLED WITH THE OTHER ARCH IT IS VERY HARD. IT IS LEFT ASSEMBLED SINCE IT WAS NOT POSSIBLE TO DISASSEMBLE IT. THIS REPORT IS FOR ONE (1) INSERTION HANDLE FOR SUPRAPATELLAR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19353496 ↗
• MalfunctionApr 22, 2024Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE DEVICES BROKE DURING IMPACTION. THERE WAS NO PATIENT HARM, NO ADVERSE EFFECTS AND NO DELAY TO THE SURGERY. THIS REPORT IS FOR ONE (1) INSERTION HANDLE FOR SUPRAPATELLAR THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19153728 ↗
• MalfunctionFeb 7, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT THE ARC INSER P/EXPERT TN P/APPROACH SUPRA DOES NOT ENTER THE DIRECTIONAL ARM EASILY; IT IS POSSIBLE TO ATTACH THESE TWO PIECES IN SURGERY BUT NOT DISARM THEM LATER; UNITS ARE LEFT; IT IS NOT POSSIBLE TO IDENTIFY WHICH OF THE TWO PIECES HAS THE PROBLEM; REVIEW. THE SURGEON MAKES THE SUGGESTION TO SEND AT LEAST 3 WATER GUIDES (3.2 L400). IT HAS NO INVOLVEMENT WITH THE PATIENT. THIS REPORT IS FOR ONE (1) INSERT-HANDLE F/ETN F/SUPRAPAT APPROACH. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18658491 ↗
• MalfunctionJan 4, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON DECEMBER 11, 2023, THERE WAS A BROKEN DRIVING CAP AND INSERTION HANDLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE INSERTION HANDLE FOR SUPRAPATELLAR. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18442674 ↗
• MalfunctionDec 20, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT DURING THE PROCEDURE ON (B)(6) 2023, THE FOLLOWING DEVICES WERE BROKEN: 1 HAND-REAMER F/MEDULL-CANAL Ø6. 1 SYNREAM REAMER HEAD Ø8.5. 1 DRILL BIT 3.2 CALIBR L145 3FLUTE F/QUIC. 1 AIM-ARM F/TIB NAIL. 1 INSERT-HANDLE F/ETN F/SUPRAPAT APPROACH. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) INSERT-HANDLE F/ETN F/SUPRAPAT APPROACH. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18369872 ↗
• MalfunctionJul 24, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, WHILE TRYING TO DRILL FOR PROXIMAL LOCKING SCREWS THROUGH THE AIMING ARM FOR A SUPRAPATELLAR TIBIAL NAIL EX THE DRILL BIT STRUCK IN THE NAIL. THE AIMING ARM WAS NOT PROPERLY TARGETING THE SCREW HOLES AND THE SURGEON HAD TO USE THE FREEHAND LOCKING TECHNIQUE TO COMPLETE THE SURGERY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH FIVE(5) MINUTES OF SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) INSERTION HANDLE FOR SUPRAPATELLAR. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17377460 ↗
• MalfunctionJul 17, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS A BROKEN INSERTION HANDLE AND IMPACTOR FROM SUPRA PATELLA TIBIAL NAIL SET. THIS REPORT INVOLVES ONE (1) INSERTION HANDLE FOR SUPRAPATELLAR. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17332514 ↗
• MalfunctionJul 12, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY FOR TIBIAL DIAPHYSEAL FRACTURE WITH EXPERT TIBIAL NAI, INSERTION HANDLE, CONNECTING SCREW AND SCREWDRIVER. INITIALLY, THE SURGEON PLANNED TO USE A TIBIAL NAIL 9MM OR LARGER, BUT BECAUSE THE PATIENT'S MEDULLARY CAVITY WAS NARROW, THE 8MM EXPERT TIBIAL NAIL WAS USED. APPROACHED FROM SUPRA-PATELLAR, THE EXPERT TIBIAL NAIL WAS INSERTED AFTER HAMMERING WITH SLIGHTLY MORE FORCE. AFTER FIXING THE DISTAL HOLE, THE PROXIMAL HOLE WAS FIXED AND THEN THE CONNECTING SCREW WAS TURNED TO DISCONNECT THE NAIL FROM THE INSERTION HANDLE, BUT IT COULD NOT BE TURNED AT ALL. THE SURGEON CHECKED THE IMAGE AND COULD SEE THAT THE NAIL TOP WAS DEFORMED, AND THE INSERTION HANDLE WAS STUCK IN THE NAIL AND TILTED INSTEAD OF ALIGNED. THEREFORE, THE SURGEON CONNECTED THE DRIVING CAP AND DRIVING HEAD TO THE INSERTION HANDLE AND LIGHTLY TAPPED IT OUT. THE LATERAL IMAGE CONFIRMED THAT THE THREADS WERE FINE, SO THE OPERATION WAS COMPLETED WITH INSERTION OF THE END CAP. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES OF SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) INSERTION HANDLE FOR SUPRAPATELLAR. THIS IS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17313187 ↗
• InjuryMay 2, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON HAD SIGNIFICANT DIFFICULTY REMOVING THE CONNECTING BOLT FROM THE TIBIA EX NAIL AT THE END OF THE CASE. SIGNIFICANT RESISTANCE WITH UNTHREADING THE BOLT. EVENTUALLY GOT IT OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 5 MINUTE SURGICAL DELAY. THIS COMPLAIN INVOLVES TWO (2) DEVICE. THIS REPORT IS FOR ONE (1) INSERTION HANDLE FOR SUPRAPATELLAR. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16852796 ↗
• MalfunctionJan 30, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON JAN 8, 2023, INSERTION HANDLE WAS NOT FITTING WITH AIMING ARM. NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) INSERTION HANDLE FOR SUPRAPATELLAR THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16266303 ↗
• MalfunctionJan 24, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SUPRAPATELLAR HANDLE, PRODUCT CODE 03.010.440, WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE INSERTION HANDLE FOR SUPRAPATELLAR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16232173 ↗
• MalfunctionJan 5, 2023Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, IT WAS DIFFICULT TO REMOVE THE CONNECTING SCREW FROM THE NAIL. THE CONNECTING SCREW EVENTUALLY DISENGAGED, BUT THE THREADS WERE DEFORMED. THE SUPRAPATELLAR INSERTION HANDLE WAS POSSIBLY DAMAGED AT THE TIP WHEN REMOVING THE NAIL, GIVEN THE RESISTANCE OF MOVING THE CONNECTING SCREW. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE INSERTION HANDLE FOR SUPRAPATELLAR. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16102392 ↗
• MalfunctionNov 18, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022 AFTER INSERTING A TIBIAL NAIL EX WITH PROXIMAL BEND THROUGH A SUPRAPATELLAR APPROACH, THE CONNECTING SCREW THAT ATTACHED THE SUPRAPATELLAR INSERTION HANDLE TO THE TIBIAL NAIL WOULD NOT LOOSEN, AND APPEARED THAT IT WAS "SPINNING" INSIDE THE HANDLE. THERE WAS A 25 MINUTES SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) INSERTION HANDLE FOR SUPRAPATELLAR. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15828844 ↗
• MalfunctionNov 4, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE FOLLOWING ITEMS WERE RETURNED TO THE TRUST FROM THEIR OUTSOURCED STERILIZATION HUB, AND WERE LABELLED AS DAMAGED: 352..085 IS BLUNT AND SO NO LONGER PERFORMS ITS FUNCTION OF END CUTTING. 03.010.523 HAS SNAPPED. THE TREADED END OF THE DRIVING CAP HAS SNAPPED/SHEARED OFF 03.010.440 THE THREADED END OF THE 03.010.523 IS SHEARED OFF INSTEAD THE HANDLE 315.290 ¿ THE DRILL BITS ARE BLUNTED AND USABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE INSERTION HANDLE FOR SUPRAPATELLAR. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15723934 ↗
• MalfunctionSep 26, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN UNKNOWN ORTHOPEDIC PROCEDURE, THE IMPACTOR BROKE FROM THE INSERTION HANDLE WHILE PERFORMING THE BACKSLAP TECHNIQUE TO CLOSE THE FRACTURE GAP AND CREATE COMPRESSION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE INSERTION HANDLE FOR SUPRAPATELLAR. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15488453 ↗
• MalfunctionMay 23, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, WHILE DOING A SUPRAPATELLAR TIBIAL NAIL CASE, THE SURGEON ATTEMPTED TO ATTACH THE AIMING ARM (03.010.441) TO THE INSERTION HANDLE (03.010.440) BUT IT WOULD NOT ATTACH. ACCORDING TO THE REPORT, THE INSERTION HANDLE WAS INSPECTED AND IT WAS FOUND THAT IT WAS BENT WHICH DID NOT ALLOW THE TWO INSTRUMENTS TO CONNECT. IT WAS REPORTED THAT THE SURGEON USED FREEHAND LOCKING TECHNIQUE TO INSERT THE SCREWS. THERE WAS A SURGICAL DELAY OF 10 MINUTES TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES ONE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14472467 ↗
• MalfunctionMar 25, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE WHILE PUTTING TRAY BACK TOGETHER IN SPD, NOTICED THE DRIVING CAP WAS BROKEN OFF INSIDE INSERTION HANDLE. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13903098 ↗
• MalfunctionFeb 28, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSERTION HANDLE WAS DISCOVERED AS BROKEN. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) INSERTION HANDLE FOR SUPRAPATELLAR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13622445 ↗
• MalfunctionDec 17, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING PATELLA NAIL INSTRUMENTATION, THE INSERTION HANDLE AND DRIVING CAP BROKE OFF. DRIVING CAP BROKE OFF INSIDE OF THE INSERTION HANDLE. NO COMPLICATION, EVERYTHING WENT FINE. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) INSERTION HANDLE FOR SUPRAPATELLAR. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13027744 ↗
• MalfunctionDec 14, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, WHEN THE SURGEON WAS DRIVING THE NAIL IN USING THE DRIVING CAP AND THE HAMMER, THE DRIVING CAP SNAPPED AT THE LEVEL OF THE THREADS, AND THE DRIVING CAP BECAME STUCK IN THE AIMING ARM FOR THE NAIL. THE THREAD WAS STUCK IN THE INSERTION HANDLE AND THE INSERTION HANDLE NEEDED TO BE REPLACED. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THIS REPORT INVOLVES ONE (1) INSERTION HANDLE FOR SUPRAPATELLAR. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13001345 ↗
• MalfunctionNov 4, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING SURGERY THE SURGEON ATTEMPTED TO ATTACH THE IMPACTOR TO THE INSERTION HANDLE. THE IMPACTOR COULD NOT BE ATTACHED TO THE INSERTION HANDLE BECAUSE THE RECESS HAD THE TIP OF A BROKEN IMPACTOR STUCK INSIDE. THIS DID NOT DELAY SURGERY BECAUSE THE SURGEON COULD ADVANCE THE NAIL WITHOUT THE IMPACTOR ATTACHED. THIS REPORT INVOLVES ONE (1) INSERTION HANDLE FOR SUPRAPATELLAR. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12751046 ↗
• MalfunctionOct 26, 2021Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12697613 ↗
• MalfunctionOct 12, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE INSERTION OF THE NAIL, THE TARGETING ARM, STATIC ARM SCREW WAS NOT ABLE TO INSERT IN THE NAIL SO IT HAD TO BE REMOVED AND INSERT MANUALLY. UPON REMOVAL OF THE INSERTION HANDLE FROM THE NAIL, THE SURGEON COULD NOT GET THE INSERTION BOLT OUT OF THE NAIL. HAMMER WAS USED TO REMOVE THE INSERTION HANDLE. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) INSERTION HANDLE FOR SUPRAPATELLAR. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12617953 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111667. One submission often covers many models, so check the product and lot details in each record.

• Z-0404-2014 · Oct 14, 2013 · Terminated
  Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthes Tibial Nail System EX to stabil