NA 359.217Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10886982197153), received between Mar 1, 2017 and Aug 26, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459653 ↗
• MalfunctionDec 12, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IN 2025, THAT THE CUTTER FOR ELASTIC NAIL WAS BROKEN WHERE THE HANDLE ATTACHES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791150 ↗
• MalfunctionNov 25, 2025Break; Break

  IT WAS REPORTED ON (B)(6) 2025, THAT 359.217 - BROKEN CUTTING MECHANISM 311.01.96 - CRACKED HANDLE. 03.110.007 - CRACKED HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23643961 ↗
• MalfunctionMar 19, 2025Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT THE ITEM HAS BEEN BROKEN/DAMAGED. THERE WERE NO PATIENT PROBLEMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21644158 ↗
• MalfunctionJun 28, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. NUMEROUS STAINS WERE ADHERING TO THE RUBBER PART OF SEVERAL PRODUCTS. THE INSTRUMENTATION NURSE, AT THE DISCRETION OF THE PRIMARY SURGEON, WIPED OFF THE STAINS WITH A TOWEL, AND THE SAID PRODUCTS WERE USED DURING THE SURGERY. IT WAS CONFIRMED THAT THE PRODUCTS WERE ALSO MORE WATER-REPELLENT THAN USUAL DURING POST-OPERATIVE CLEANING. THIS REPORT IS FOR ONE CUTTER F/TEN THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19637096 ↗
• MalfunctionJun 14, 2024Failure to Cut; Material Deformation; Failure to Cut; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024 THE SURGEON TRIED TO CUT THE NAIL ONCE INSERTED BUT THE CUTTER DIDN¿T CUT THE NAIL IT JUST BENT IT, AFTER MULTIPLE ATTEMPTS THE SURGEON USED ANOTHER DEVICE. THERE WAS A TEN (10) MINUTES OF SURGICAL DELAY WHILST THEY TRIED TO CUT THE NAIL AND FIND ANOTHER INSTRUMENT TO CUT THE IMPLANT. THE SURGEON HAD TO CUT THE NAIL WITH A BOLT CUTTER. THERE WAS NO PATIENT CONSEQUENCE. PATIENT OUTCOME IS REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) CUTTER FOR TI ELASTIC NAILS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19538790 ↗
• MalfunctionMar 21, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE INSTRUMENT WAS SENT BACK TO THE LOAN TEAM TAGGED AS BROKEN. A HOSPITAL REPRESENTATIVE SAID THAT ONE OF THE REGISTRARS COULDN'T GET IT TO CUT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE CUTTER FOR TI ELASTIC NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16582350 ↗
• MalfunctionJul 7, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT THE CUTTER BROKE DUE TO WEAR AND TEAR. THIS WAS DISCOVERED AFTER THE PROCEDURE. THERE WAS NO IMPACT TO PATIENT AND THE PROCEDURE. THIS REPORT IS FOR ONE (1) CUTTER FOR TI ELASTIC NAILS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14948387 ↗
• MalfunctionMar 25, 2022Break; Break

  DEVICE REPORT FROM SYNTHES AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THE CUTTING AREA OF THE CUTTER BROKE OFF. THIS WAS FOUND DURING ROUTINE INSPECTION OF A LOAN KIT; THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13902909 ↗
• MalfunctionDec 1, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE CUTTER FOR TITANIUM ELASTIC NAILS WAS BROKEN, TWO (2) 2.7MM REAMING ROD PUSHER 450MM LONG AND ONE (1) HELICAL BLADE/SCREW MEASURING DEVICE PIECE WERE BROKEN OFF. WHILE, THE STARDRIVE SCREWDRIVER SHAFT T25 3.5MM HEXAGONAL/SELF-RETAIN AND CANNULATED 3.5MM HEXAGONAL SCREWDRIVER SHAFT HEAD WERE STRIPPED. THERE WAS A SURGICAL DELAY OF A COUPLE OF MINUTES. FRAGMENTS WERE GENERATED AND INSTRUMENTS WERE REMOVED. IT IS UNKNOWN IF PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE IS PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10928601 ↗
• MalfunctionSep 30, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE CUTTER BROKE DURING USE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED WITH ANOTHER CUTTER. THERE WAS NO HARM TO THE PATIENT. THIS REPORT INVOLVES ONE (1) CUTTER FOR TI ELASTIC NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10606007 ↗
• MalfunctionJul 22, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2020, A CUTTER BLADE WAS ROUNDED AND DULL. THE ISSUE WAS DISCOVERED DURING CLEANING. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A CUTTER FOR TITANIUM (TI) ELASTIC NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10310744 ↗
• MalfunctionMay 19, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NORWAY AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE DURING THE CLEANING/STERILIZATION A CHIP WAS FOUND OFF. THE SURGERY OUTCOME WAS UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10072551 ↗
• MalfunctionOct 9, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE CUTTER FOR TITANIUM ELASTIC NAILS SNAPPED HALF WHEN IT DROPPED ON THE FLOOR AFTER THE SURGERY. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. IT DID NOT AFFECT THE PATIENT AS THE EVENT OCCURRED AFTER THE SURGERY. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) CUTTER FOR TI ELASTIC NAILS. THIS IS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9170241 ↗
• MalfunctionSep 17, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN ORTHOPEDIC PROCEDURE, THE SURGEON DROPPED THE UNKNOWN RATCHET WRENCH/ CUTTER FOR TITANIUM ELASTIC NAIL FROM THE TITANIUM ELASTIC NAIL ON THE GROUND AND THE DEVICE BROKE. ANOTHER WRENCH WAS GRABBED TO COMPLETE THE PROCEDURE. NO FRAGMENTS WERE GENERATED. THERE WAS A ONE (1) MINUTE OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNKNOWN TITANIUM ELASTIC NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) CUTTER FOR TI ELASTIC NAILS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9079174 ↗
• MalfunctionSep 3, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE CUTTER FOR TITANIUM ELASTIC NAILS APPEARED TO BE BROKEN. WE WERE NOTIFIED POSTOPERATIVELY, HOWEVER, DO NOT HAVE ANY INDICATION WHEN THIS ISSUE OCCURRED. IT IS ALSO UNKNOWN IF THERE WERE ANY SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8956718 ↗
• MalfunctionAug 17, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE CUTTER BROKE. IT IS UNKNOWN IF THERE WAS SURGERY OR PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7794837 ↗
• MalfunctionMar 1, 2017Break; Break

  IT WAS REPORTED THAT THE CUTTER FOR ELASTIC NAILS INSTRUMENT WAS FOUND SEPARATED AFTER DECONTAMINATION. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. DURING INVESTIGATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THE RETURNED ELASTIC NAIL CUTTER WAS CONFIRMED TO BE BROKEN AT THE WELD BETWEEN THE SHAFT AND THE CUTTING HEAD. THE DOWEL PIN IN THE HANDLE WAS FOUND TO BE PROTRUDING FROM THE HANDLE APPROXIMATELY 1.5MM. THE SHAFT HAS IMPACT MARKS ACROSS THE LENGTH OF THE DEVICE, ALTHOUGH THE SHAFT IS MARKED "DO NOT IMPACT". THE DEVICE HAS SOME RUST AROUND THE ETCHING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6367589 ↗