NA 311.01.98Recalls & reported problems
Synthes GmbH · HANDLE WITH MINI QUICK COUPLING · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587035628), received between Oct 3, 2023 and Jul 2, 2024 — classified as 2 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.
Reports received per month
Most reported problems
Device problems
- Break1
- Device-Device Incompatibility1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVER SHAFT JAMMED INTO THE WRONG HANDLE TO COVER CASE. IT IS NOW STUCK AND WON'T COME OUT. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) HANDLE WITH MINI QUICK COUPLING. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19654069 ↗MalfunctionOct 3, 2023Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HANDLE IN QUESTION SPLIT INTO TWO PARTS. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A HANDLE WITH MINI QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 17860822 ↗
Other TAP, BONE devices
- NA 311.43Synthes GmbH · TAP, BONE176 reports
- NA 311.01Synthes GmbH · TAP, BONE106 reports
- NA 311.431Synthes GmbH · TAP, BONE70 reports
- NA 03.424.124Synthes GmbH · TAP, BONE1 recall7 reports
- NA 03.424.126Synthes GmbH · TAP, BONE1 recall0 reports
- A.L.P.S.® 8241-50-170Biomet Orthopedics, LLC · TAP, BONE1 recall0 reports
- N/A 876-474Medtronic Sofamor Danek, Inc. · TAP, BONE1 recall0 reports
- NA 311.44Synthes GmbH · TAP, BONE41 reports
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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