NA 359.221Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982197238), received between Dec 5, 2018 and Apr 19, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NORWAY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHEN CLEANING THE HAMMER AFTER USE, IT WAS DISCOVERED THAT A CHIP WAS GONE FROM THE HAMMER¿S HEAD. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE COMBINED HAMMER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16768829 ↗
• MalfunctionNov 23, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM (B)(6) 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 COMBINED HAMMER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15853495 ↗
• MalfunctionMar 10, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN 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) COMBINED HAMMER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13721565 ↗
• MalfunctionAug 17, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE SURGERY. AFTER THE SURGERY, THE HAMMER BROKE. ALL GENERATED FRAGMENTS ARE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) COMBINED HAMMER. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12332326 ↗
• MalfunctionJul 29, 2021Break; Break

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED PARTICLES BEGAN TO CRUMBLE OFF THE DEVICE DURING USE. THERE WAS NO PATIENT IMPACT. THIS REPORT IS FOR A HAMMER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12247651 ↗
• MalfunctionJun 19, 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 SURGERY THAT THE HAMMER BROKE DURING HAMMERING. THERE WAS NO SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. THIS REPORT INVOLVES ONE (1) COMBINED HAMMER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10174056 ↗
• MalfunctionDec 5, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE USING THE TITANIUM ELASTIC NAIL SYSTEM (TEN). DURING THE SURGERY, THE BLUE PART OF THE INSERTER FOR TEN SOMEHOW BROKE, THE COMBINED HAMMER FOR TEN DID NOT SLIDE SMOOTHLY, AND THE SURFACE CONDITION OF THE HAMMER GUIDE FOR TEN WAS BAD. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR ONE (1) COMBINED HAMMER. THIS IS REPORT 3 OF 3 FOR PC-(B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8132958 ↗