NA 03.430.002Recalls & reported problems
Synthes GmbH · SCREWDRIVER HANDLE/ LARGE AO QUICK COUPLING · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982340801), received between May 13, 2026 and Sep 25, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility3
- Detachment of Device or Device Component2
- Break1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Device-Device Incompatibility
It was reported that the driving cap pin was not in the middle and did not hold the top part in place. This issue caused the spring to become loose. The Perc clamp was bent and not collinear when tightening down. The screwdriver handle not locking in to hold quick connect screwdriver.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896791 ↗MalfunctionAug 14, 2026Break; Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50262637 ↗MalfunctionJul 7, 2026Detachment of Device or Device Component; Device-Device Incompatibility
IT WAS REPORTED ON (B)(6) 2026, THAT QUICK COUPLING HANDLE WAS NOT ENGAGING POWER SHAFT. UPON INSPECTION, A SMALL METAL PIECE FELL OUT OF THE HANDLE AND WOULD NOT TAKE ANY ATTACHMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25734115 ↗MalfunctionJun 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THE QUICK CONNECT OF HANDLE IS NO LONGER ATTACHED TO THE HANDLE. NO PATIENT HARM. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25637256 ↗MalfunctionMay 13, 2026Device-Device Incompatibility
IT WAS REPORTED ON AN UNKNOWN DATE THAT THE REPORTER HAD A VOLT SMALL FRAG CASE YESTERDAY AND THE QUICK CONNECT HANDLE WOULD NOT RETAIN THE SCREWDRIVER. WE TRIED TO DRIVER ON A DIFFERENT HANDLE AND IT WORKED, SO IT WAS CONFIRMED THAT THE HANDLE WAS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25163153 ↗
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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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