ACIS 03.841.059Recalls & reported problems
Synthes GmbH · INNER SHAFT-STANDARD FOR ACIS IMPLANT INSERTER · Class 1
All models of ACIS (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034732398), received between Sep 15, 2020 and Feb 10, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device-Device Incompatibility1
Patient problems
- No Consequences Or Impact To Patient1
- Paralysis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT (ICU) AND HAD NOT PROGRESSED VERY WELL.
Patient problems: Paralysis
MAUDE report 13508324 ↗MalfunctionSep 15, 2020Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, THE CAGE CANNOT BE TIGHTENED ON THE ACIS INSERTER INSTRUMENT, WHICH RESULTED IN A WOBBLE. THE CAGE WAS IMPLANTED EVEN THOUGH THE IMPLANT HOLDER WAS DEFECTIVE. NO REVISION REQUIRED. SURGERY COMPLETED SUCCESSFULLY WITHOUT ANY REPORTED DELAY. NO ADVERSE PATIENT HARM. CONCOMITANT DEVICES REPORTED: INNER SHAFT STD/LRG W/STOP F/03.841.050 (PART # 03.841.060, LOT # T171647, QUANTITY 1); CAGE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1); ACIS IMPLANT INSERTER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1); INSERTION INSTRUMENT KNOB (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) INNER SHAFT-STANDARD FOR ACIS IMPLANT INSERTER. THIS IS REPORT 1 OF 5 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10537527 ↗
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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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