NA 359.218Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10886982197207), received between Mar 27, 2017 and Aug 7, 2025 — classified as 35 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (20 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2025Device-Device Incompatibility; Material Integrity Problem; Mechanical Jam; Device-Device Incompatibility; Material Integrity Problem; Mechanical Jam

  IT WAS REPORTED THAT THE TENS INSERTER AND DRIVING CAP BECAME STUCK. BOTH THE INSERTER AND DRIVING CAP WERE DAMAGED. THERE LOOKS LIKE THERE IS SOME DAMAGE TO THE PROXIMAL THREADS NOT ALLOWING THE IMPACTOR TO FULLY ENGAGE. THEY HAVE ORDERED A NEW DRIVING CAP HOWEVER IT STILL WILL NOT THREAD INTO THE INSERTER. HOSPITAL REQUIRE A NEW TENS INSERTER. NO PATIENT INVOLVEMENT, THE TWO INSTRUMENTS BECAME STUCK WHEN TRYING TO DISASSEMBLE THEM AT THE END OF THE CASE. NO DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22745022 ↗
• MalfunctionJun 23, 2025Break; Break

  IT WAS REPORTED THAT THE CONNECTOR WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22308878 ↗
• MalfunctionMar 31, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE SCREW THREAD IS STRIPPED AND UNABLE TO CONNECT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21733782 ↗
• MalfunctionMar 17, 2025Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PRODUCT WAS UNABLE TO BE STERILIZED/ASSEMBLED. ALSO THERE WAS CHIPPING AND CRACKING. IT WAS UNABLE TO BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619010 ↗
• MalfunctionAug 28, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN NORWAY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2023, PRE-OPERATIVELY THE THREADS WERE BROKEN, AND THE TWO INSTRUMENTS DOESN`T FIT. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HAMMER GUIDE FOR TI ELASTIC NAILS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17631190 ↗
• MalfunctionJun 28, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENTS WERE BROKEN. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE HAMMER GUIDE FOR TI ELASTIC NAILS. THIS IS REPORT 4 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17216721 ↗
• MalfunctionJun 21, 2023Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE THREADED ROD IS DAMAGED AND CAN NO LONGER BE SCREWED IN. SURGERY COULD BE PERFORMED WITHOUT DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) HAMMER GUIDE F/TEN THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17170866 ↗
• MalfunctionMay 11, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN POLAND AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A NAIL (TEN) WAS INTRODUCED DURING THE PROCEDURE. THE EXTENSION WAS SCREWED PROPERLY INTO THE MALLET, DURING THE BEATING THE HANDLE BROKE. THE DAMAGED PART REMAINS IN THE HANDGRIP. THERE WERE NO CONSEQUENCES FOR THE PATIENT REPORTED. THE PROCEDURE WAS COMPLETED, AND THE PHYSICIAN USED NAIL. THIS REPORT INVOLVES ONE (1) HAMMER GUIDE FOR TI ELASTIC NAILS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16910358 ↗
• MalfunctionMar 24, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT DURING LOAN KIT INSPECTION ON (B)(6) 2023, THE LOAN KIT TECHNICIAN FOUND THAT THE INSTRUMENTS WERE STUCK TOGETHER. THERE WAS NO REPORTED PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE HAMMER GUIDE FOR TI ELASTIC NAILS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16610913 ↗
• MalfunctionDec 21, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE THREADS HAD BEEN DAMAGED AND THE INSTRUMENT WAS UNUSABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE HAMMER GUIDE FOR TI ELASTIC NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16022381 ↗
• MalfunctionNov 23, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THE SURGERY WITH THE PRODUCTS IN QUESTION WHICH THE HOSPITAL BOUGHT IN JUNE. WHEN THE PRODUCTS WERE USED FOR THE FIRST TIME AT THE END OF OCTOBER AT THE TIME OF TITANIUM ELASTIC NAIL EXTRACTION, METAL POWDER CAME OUT FROM THEM. THIS IS THOUGHT TO HAVE BEEN CAUSED BY FRICTION DUE TO SLIDING METAL-TO-METAL, BUT THIS DID NOT OCCUR ON THE LOANED ITEMS PRIOR TO PURCHASE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A HAMMER GUIDE FOR TI ELASTIC NAILS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15853527 ↗
• MalfunctionNov 8, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE THREAD OF INSERTER HANDLE IS BROKEN IN SLAP HAMMER GUIDE AND IT IS NOT POSSIBLE TO CLOSE. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) HAMMER GUIDE FOR TI ELASTIC NAILS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15755856 ↗
• MalfunctionNov 1, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SCREW WOULD NOT ENGAGE WITH THE DRIVER DURING A PROCEDURE. THE SURGEON OPENED ANOTHER INSTRUMENT TRAY TO CONTINUE THE PROCEDURE. THERE WAS A 15 MINUTE DELAY AS A RESULT OF THIS EVENT. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE HAMMER GUIDE FOR TI ELASTIC NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15708496 ↗
• MalfunctionOct 17, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE ITEMS WERE BROKEN DURING A PROCEDURE. THERE WAS A SURGICAL DELAY OF 15 MINUTES AS A RESULT. ANOTHER KIT WAS OPENED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE HAMMER GUIDE FOR TI ELASTIC NAILS. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15616344 ↗
• MalfunctionJul 15, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT FOLLOWING A PROCEDURE ON (B)(6) 2022, IT WAS NOTICED THAT THE CUTTER WAS BROKE AND THE HAMMER GUIDE FOR THE TEN INSERTER BECAME JAMMED IN THE INSERTER. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED THAT THE HAMMER GUIDE WAS UNABLE TO BE DISASSEMBLED FROM THE INSERTER. THIS REPORT IS FOR A HAMMER GUIDE FOR TI ELASTIC NAILS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15027497 ↗
• MalfunctionJun 10, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION WITH THE TITANIUM ELASTIC NAIL (TEN) FOR THE FRACTURE OF THE DIAPHYSEAL RIGHT TIBIA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, IT WAS CONFIRMED THAT THREAD PARTS OF THE EXTRACTION PLIERS AND THE HAMMER GUIDE WERE BROKEN. X-RAY TAKEN ON AN UNKNOWN DATE CONFIRMED THAT THERE ARE NO PIECES LEFT IN THE PATIENT. THE EXTRACTION PLIERS AND THE HAMMER GUIDE HAVE BEEN USED FOR THE FIRST TIME SINCE PURCHASE. IT WAS UNKNOWN WHEN THE DEVICES WERE BROKEN. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) HAMMER GUIDE FOR TI ELASTIC NAILS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14652361 ↗
• MalfunctionMar 10, 2022Unexpected Therapeutic Results; Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A REMOVAL SURGERY. WHEN SLIDING THE HAMMER TO STRIKE, THE HAMMER AND GUIDE BECAME STUCK BADLY, MAKING IT DIFFICULT TO PROCEED WITH THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE OPERATION TIME WAS EXTENDED LESS THAN THIRTY (30) MINUTES. THE PATIENT WAS REPORTED AS STABLE. THIS REPORT INVOLVES ONE (1) HAMMER GUIDE FOR TI ELASTIC NAILS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13721501 ↗
• MalfunctionFeb 1, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE THREAD OF THE HAMMER GUIDE WAS STRIPPED. NO FURTHER INFORMATION PROVIDED. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS ALSO IDENTIFIED THAT THE HAMMER GUIDE DISTAL END HAD BROKEN AND THE BROKEN PIECE WAS NOT RETURNED FOR INVESTIGATION. THIS DEVICE CONDITION WAS EVALUATED AND DETERMINED TO BE REPORTABLE ON (B)(6) 2022. THIS REPORT IS FOR ONE (1) HAMMER GUIDE FOR TI ELASTIC NAILS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13416362 ↗
• MalfunctionNov 10, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, DURING A SURGERY THE CONDUCTIVE ROD WAS FOUND STUCK INSIDE THE INSERT HANDLE AND THE HAMMER GUIDE NO LONGER SCREWS INTO THE HANDLE. THIS REPORT IS FOR (1) HAMMER GUIDE FOR TI ELASTIC NAILS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12788057 ↗
• MalfunctionOct 29, 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 THE CUSTOMER REPORTS KNOCKED OUT THREAD. THIS REPORT IS FOR ONE (1) HAMMER GUIDE F/TEN. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12719475 ↗
• MalfunctionJul 23, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED AN INSTRUMENT WERE DAMAGED FOLLOWING A CASE. THERE WAS NO DELAY TO THE SURGERY AND NO PATIENT IMPACTED REPORTED. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE DISTAL THREADS WERE BROKEN. THIS REPORT IS FOR A HAMMER GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12216431 ↗
• MalfunctionNov 3, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020 THAT THE ROD IMPACTOR AND GUIDE TUBE SHOWED DAMAGE TO THE STRUCTURE THAT MADE IT IMPOSSIBLE TO USE DURING THE PROCEDURE, AS THEY WERE STUCK. THERE WAS A SURGICAL DELAY IN THE PROCEDURE UNTIL ANOTHER INSTRUMENT REPLACEMENT WAS FOUND. THIS REPORT IS FOR ONE (1) HAMMER GUIDE FOR TI ELASTIC NAILS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10779174 ↗
• MalfunctionJun 9, 2020Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICES REPORTED: INSERTER F/TEN (PART NUMBER 359.219, LOT 4L88024, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10133552 ↗
• MalfunctionFeb 5, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE THREADS OF THE HAMMER GUIDE ARE WORN DOWN AND IT CAN¿T SCREW INTO THE DEDICATED HOLE. IT CANNOT CONNECT TO THE MATCHING HANDLE. THIS REPORT IS FOR ONE HAMMER GUIDE FOR TI ELASTIC NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9670432 ↗
• MalfunctionNov 7, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2019 DURING AN INSTRUMENTS PRESENTATION TO HCPS AT HOSPITAL (NO PATIENT INVOLVEMENT) THE BRAND NEW INSTRUMENTS WERE NOT POSSIBLE TO DISASSEMBLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS 2 OF 2 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9291852 ↗