NA 03.226.006Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982077066), received between Jan 24, 2019 and Oct 4, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2021Device-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, IT WAS NOTIFIED THAT THE COMPRESSION SLEEVE HANDLE NO LONGER CONNECTS PROPERLY TO THE 2.4- OR 3.0-MM COMPRESSION SLEEVES. IT DOES NOT SLIDE INTO THE PROPER RECESS TO ¿LOCK¿ INTO PLACE AND IS THEREFORE LOOSE. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: 2.4/3.0MM HEADLESS COMPRESSION (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) COMPRESSION SLEEVE HANDLE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12572699 ↗
• MalfunctionMar 8, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRONGS AT THE DISTAL END OF THE COMPRESSION SLEEVE HANDLE, WERE BENT AND WOULD NO LONGER FIT THROUGH THE COMPRESSION SLEEVE, FOR SCREW INSERTION. THERE WAS NO PATIENT OR SURGERY INVOLVEMENT. THIS REPORT INVOLVES ONE (1) COMPRESSION SLEEVE HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11439463 ↗
• MalfunctionJan 24, 2019Break; Break

  IT WAS REPORTED THAT DURING ROUTINE INSPECTION OF A LOANER SET ON AN UNKNOWN DATE, THE COMPRESSION SLEEVE HANDLE WAS FOUND TO BE BROKEN. THE PART WAS IMMEDIATELY REMOVED FROM THE SET AND IS AVAILABLE FOR FURTHER EVALUATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A COMPRESSION SLEEVE HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8273593 ↗