NA 03.430.004Recalls & reported problems
Synthes GmbH · RATCHETING HANDLE/ LARGE AO QUICK COUPLING · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982340825), received between Nov 6, 2025 and Jan 16, 2026 — classified as 9 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility5
- Break4
Patient problems
- No Clinical Signs, Symptoms or Conditions9
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 16, 2026Device-Device Incompatibility
IT WAS REPORTED THAT SEVERAL INSTRUMENTS HAD ISSUES. THERE WAS NO PATIENT CONSEQUENCE. SCREWDRIVER SHAFT: STRIPPED HEAD FROM USAGE. SCREWDRIVER SHAFT: STUCK IN SHAFT OF HANDLE, UNABLE TO GET IT OUT UNTIL AFTER CASE, SOAKED IN SALINE / WATER (WAS ABLE TO GET OUT A FEW DAYS AFTER).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24099987 ↗MalfunctionJan 16, 2026Device-Device Incompatibility
IT WAS REPORTED THAT SEVERAL INSTRUMENTS HAD ISSUES. THERE WAS NO PATIENT CONSEQUENCE. SCREWDRIVER SHAFT: STRIPPED HEAD FROM USAGE. SCREWDRIVER SHAFT: STUCK IN SHAFT OF HANDLE, UNABLE TO GET IT OUT UNTIL AFTER CASE, SOAKED IN SALINE / WATER (WAS ABLE TO GET OUT A FEW DAYS AFTER).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24099983 ↗MalfunctionJan 16, 2026Device-Device Incompatibility
IT WAS REPORTED THAT SEVERAL INSTRUMENTS HAD ISSUES. THERE WAS NO PATIENT CONSEQUENCE. SCREWDRIVER SHAFT: STRIPPED HEAD FROM USAGE. SCREWDRIVER SHAFT: STUCK IN SHAFT OF HANDLE, UNABLE TO GET IT OUT UNTIL AFTER CASE, SOAKED IN SALINE / WATER (WAS ABLE TO GET OUT A FEW DAYS AFTER).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24099982 ↗MalfunctionJan 16, 2026Device-Device Incompatibility
IT WAS REPORTED THAT SEVERAL INSTRUMENTS HAD ISSUES. THERE WAS NO PATIENT CONSEQUENCE. SCREWDRIVER SHAFT: STRIPPED HEAD FROM USAGE. SCREWDRIVER SHAFT: STUCK IN SHAFT OF HANDLE, UNABLE TO GET IT OUT UNTIL AFTER CASE, SOAKED IN SALINE / WATER (WAS ABLE TO GET OUT A FEW DAYS AFTER).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24099981 ↗MalfunctionJan 16, 2026Device-Device Incompatibility
IT WAS REPORTED THAT SEVERAL INSTRUMENTS HAD ISSUES. THERE WAS NO PATIENT CONSEQUENCE. SCREWDRIVER SHAFT: STRIPPED HEAD FROM USAGE. SCREWDRIVER SHAFT: STUCK IN SHAFT OF HANDLE, UNABLE TO GET IT OUT UNTIL AFTER CASE, SOAKED IN SALINE / WATER (WAS ABLE TO GET OUT A FEW DAYS AFTER).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24099558 ↗MalfunctionNov 6, 2025Break; Break
IT WAS REPORTED THE RATCHETING SCREWDRIVER HANDLE WAS DISCOVERED BROKEN BY THE STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23488768 ↗MalfunctionNov 6, 2025Break; Break
IT WAS REPORTED THE RATCHETING SCREWDRIVER HANDLE WAS DISCOVERED BROKEN BY THE STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23488735 ↗MalfunctionNov 6, 2025Break; Break
IT WAS REPORTED THE RATCHETING SCREWDRIVER HANDLE WAS DISCOVERED BROKEN BY THE STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23488692 ↗MalfunctionNov 6, 2025Break; Break
IT WAS REPORTED THE RATCHETING SCREWDRIVER HANDLE WAS DISCOVERED BROKEN BY THE STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23488620 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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