ABC2 FJ911RRecalls & reported problems
Aesculap AG · ABC SELF-LOCKING ASSISTANCE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04038653449941), received between Oct 18, 2021 and Nov 8, 2022 — classified as 3 injuries.
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.
Most reported problems
Device problems
- Break1
- Fracture1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 8, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO AESCULAP INC. THAT A ABC SELF-LOCKING ASSISTANCE4.0X14MM (ITEM # FJ911R) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SILVER LOCKING RING DID NOT RAISE TO LOCK THE SCREW IN PLACE WHEN THE SCREW DRIVER WAS DISENGAGED. IT WAS REPORTED THAT THE THREADS OF A LOCKING ASSISTANCE TOOL HAD BROKEN OFF INSIDE THE LOCKING RING, CAUSING THE SCREW TO BECOME STRIPPED. THE COMPLAINT DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AS A RESULT OF THIS EVENT ADDITIONAL MEDICAL INTERVENTION WAS REPORTED. THE SURGEON HAD TO REMOVE FIVE (5) SUCCESSFULLY IMPLANTED SCREWS AND REMOVED THE STRIPPED SCREW WITH LOCKING PLIERS. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AIC REFERENCE CC (B)(4). THE ASSOCIATED MEDWATCH REPORTS #: 2916714-2022-00108 (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15751796 ↗InjuryOct 18, 2021Fracture; Fracture
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FJ911R - ABC SELF-LOCKING ASSISTANCE. ACCORDING TO THE COMPLAINT DESCRIPTION, THE INSTRUMENT BROKE DURING SURGERY. WORKING END OF LOCKING ASSISTANCE TOOL BROKE OFF IN SCREW HEAD WHILE IN USE. BOTH PIECES OF LOCKING ASSISTANCE TOOL REMOVED FROM PATIENT. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12647853 ↗InjuryOct 18, 2021Break; Break
NO UPDATES REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12647846 ↗
Other SCREWDRIVER devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 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.
How reports and recalls are matched · Editorial policy · Report an error on this page