NA 214.540Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982154163), received between Jan 19, 2018 and Dec 4, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON NOVEMBER 13, 2023, SALES REPRESENTATIVE RECEIVED NOTIFICATION FROM THE NURSE WHO WAS IN A CASE WITH A SPINE SURGEON WHO WAS PERFORMING A PARS REPAIR IN THE SPINE OF A PATIENT. THE NURSE INFORMED THE SALES REPRESENTATIVE THAT A PARTIALLY THREADED 4.5 CANNULATED SCREW HAD BROKEN INSIDE THE PATIENT, AND THAT THERE WOULD BE A RETAINED PIECE OF THE SCREW. RETAINED HARDWARE FRAGMENT IN PATIENT. CONSULTANT WAS AT A DIFFERENT FACILITY AND HAD NO PRIOR USE OF THIS CASE BEFORE THE NURSE IN THE SURGEON'S ROOM CONTACTED. SURGERY WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WAS A PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) 4.5MM CANNULATED SCREW PARTIALLY THREADED/40MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18257352 ↗
• InjuryMay 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION OF HARDWARE DUE TO FALL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. PATIENT CONSEQUENCE IS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 4.5 CANNULATED SCREW PARTIALLY THRD/40. THIS REPORT IS 1 OF 2 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11809138 ↗
• MalfunctionMay 6, 2020Crack; Crack

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, THE THREADS OF 4.5MM CANNULATED SCREW 40MM (SS) STRIPPED OFF OF SCREW COMPLETELY UPON INSERTION OVER GUIDE WIRE. THERE WAS AN UNSPECIFIED AMOUNT OF SURGICAL DELAY DURING THE PROCEDURE. FRAGMENTS WERE GENERATED, BUT WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICES REPORTED: GUIDE WIRE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1) SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR 1 4.5MM CANNULATED SCREW PARTIALLY THREADED/40MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 10028693 ↗
• MalfunctionOct 16, 2019Break; Break

  THE INITIAL COMPLAINT WAS REVIEWED AND FOUND TO BE COVERED UNDER PERIODIC SUMMARY REPORTING AND NOT INDIVIDUAL 3500A REPORTING. THIS EVENT WILL BE CAPTURED ON THE PERIODIC SUMMARY REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9197895 ↗
• MalfunctionJan 19, 2018Break; Break

  IT WAS REPORTED THAT THE THREADS BROKE OFF A 4.5 MM CANNULATED SCREW (LENGTH: 40 MM) DURING A PATELLA REPAIR PROCEDURE. SCREW REMOVED BUT SOME PIECES REMAINED IN PATELLA. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY IN SURGERY. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7207324 ↗