NA 03.008.011Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982066909), received between Jan 24, 2017 and Aug 24, 2023 — classified as 8 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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE INSTRUMENTS WERE DELIVERED WITH BLOOD RESIDUES. THIS REPORT INVOLVES ONE (1) SPIRAL BLADE INSERTER FOR HINDFOOT ARTHRODESIS NAIL-EX. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17612132 ↗
• MalfunctionAug 24, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN LUXEMBOURG AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2023, THE INSTRUMENTS WERE DELIVERED WITH BLOOD RESIDUES. THIS REPORT INVOLVES ONE (1) SPIRAL BLADE INSERTER FOR HINDFOOT ARTHRODESIS NAIL-EX. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17612108 ↗
• MalfunctionAug 24, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE INSTRUMENTS WERE DELIVERED WITH BLOOD RESIDUES. THIS REPORT INVOLVES ONE (1) SPIRAL BLADE INSERTER FOR HINDFOOT ARTHRODESIS NAIL-EX. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17612068 ↗
• MalfunctionApr 25, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A HIND FOOT NAIL ORTHOPEDIC SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE SPIRAL BLADE DEVICE COULD NOT GET THE BLADE INSERTER THROUGH THE AIMING ARM ADAPTER DEVICE. IT WAS REPORTED THAT THE SURGEON ATTEMPTED THIS A COUPLE OF TIMES BUT HAD TO GO TO THE SPIRAL BLADE EXTRACTION TOOL TO INSERT THE BLADE. ACCORDING TO THE REPORT, THE SURGEON ATTEMPTED TO GET THE INSERTER THROUGH THE AIMING ADAPTER BUT STILL WOULD NOT GO THROUGH. IT WAS REPORTED THAT THE REPORTER CLAIMED THAT IT LOOKED LIKE THAT THE INSERTER HAD A BIGGER DIAMETER THAN THE HOLE OF THE ADAPTER. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 10 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) SPIRAL BLADE INSERTER F/EXPERT HAN DEVICE. THIS COMPLAINT INVOLVES 3 DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14192933 ↗
• MalfunctionMar 3, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT SPIRAL BLADE INSERTER WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) SPIRAL BLADE INSERTER FOR HINDFOOT ARTHRODESIS NAIL-EX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11405698 ↗
• MalfunctionMar 25, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE DEVICE BROKE DURING A PROCEDURE ON AN UNKNOWN DATE DUE TO FATIGUE OF MATERIAL. THE PROCEDURE WAS SUCCESSFULLY FINISHED WITH A 20 MINUTE SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9878390 ↗
• MalfunctionSep 12, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SPIRAL BLADE INSERTER WAS BROKEN. THE METAL RETAINING CLIP IN THE PROXIMAL END OF THE SPIRAL BLADE INSERTER BROKE. IT NO LONGER KEEPS THE SLEEVE ON AND DOES NOT SELF-RETAIN TO THE SHAFT. THE ISSUE WAS DISCOVERED AFTER OPENING THE TRAY. THERE WAS NO PATIENT INVOLVEMENT.  THIS REPORT IS FOR ONE (1) SPIRAL BLADE INSERTER FOR HINDFOOT ARTHRODESIS NAIL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9010115 ↗
• MalfunctionJan 24, 2017Break; Break

  IT WAS REPORTED THAT THE SPIRAL BLADE INSERTER WAS FOUND BROKEN AT THE LOAN SET. THE T-SHAPE END OF THE INSERTER IS LOOSE. THE INSTRUMENT DID NOT BROKE AT THE LOAN DEPARTMENT. NO PATIENT INVOLVEMENT.. THE PART HAS A BROKEN PIN AND HAS A VERY USED CONDITION. THIS COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6273723 ↗