NA 03.037.116Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982070579), received between Feb 11, 2019 and May 23, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE COMPRESSION NUT WAS MOUNTED ON THE AMAR GUIDE SHEATH, BUT UPON INSPECTION IT WAS CLEAR THAT IT COULD NOT BE REMOVED BECAUSE IT WAS DENTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077496 ↗
• MalfunctionFeb 5, 2024Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DEVICES WERE UNABLE TO BE STERILIZED/ASSEMBLED. THEY WERE CHIPPING AND CRACKING. THEY ARE UNABLE TO BE USED. THIS REPORT IS FOR ONE (1) COMPRESSION NUT FOR SCREW INSERTER THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18641774 ↗
• MalfunctionDec 28, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, A COMPRESSION DEVICE WOULD NOT THREAD ON THE T HANDLE INSERTER. THE THREADS APPEARED TO BE DAMAGED. THERE WAS NO SURGICAL DELAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT INVOLVES ONE COMPRESSION NUT FOR SCREW INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18415935 ↗
• MalfunctionNov 14, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS FOUND THAT THE THREADS OF THE COMPRESSION NUT IN QUESTION WERE WEARING OUT. THE WORN THREADING WAS CAUSING THE NUT TO GET CAUGHT IN THE JIG. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A COMPRESSION NUT FOR SCREW INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18131017 ↗
• MalfunctionApr 11, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE COMPRESSION NUTS THREAD WAS BROKEN, SO THE NUT DIDN¿T SCREW IN ORDER TO DO COMPRESSION. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THERE WERE NO PATIENT OUTCOME/ CONSEQUENCES. THIS REPORT IS FOR ONE (1) COMPR-NUT F/INSERTER F/TFNA SCR THIS IS REPORT 1 OF 1 FOR COMPLAINT#: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16716344 ↗
• MalfunctionFeb 11, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THE THREADS ON THE SCREW INSERTER WERE DISCOVERED TO BE STRIPPED AND THE COMPRESSION SLEEVE WAS UNABLE TO THREAD OVER THE INSERTION HANDLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT MEDICAL PRODUCTS: INSERTION HANDLE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A COMPRESSION NUT FOR SCREW INSERTER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8327301 ↗