Instinct® Java™ System 046W1AN00640Recalls & reported problems
Zimmer Spine · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024342187), received between Jun 18, 2020 and Aug 29, 2022 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fracture4
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 29, 2022Fracture; Fracture
IT WAS REPORTED THAT A WAREHOUSE FOUND TWO FINAL DRIVERS BOTH WITH FRACTURED TIPS DURING INSPECTION AFTER THEY WERE RETURNED FROM A HOSPITAL. THE HOSPITAL DID NOT PROVIDE ANY PATIENT OR SURGICAL INFORMATION WITH THE RETURNED DEVICES. THIS IS REPORT ONE OF TWO FOR THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 15310867 ↗MalfunctionMay 16, 2022Fracture; Fracture
IT WAS REPORTED THAT THE TIPS OF THREE INSTINCT JAVA SCREWDRIVERS BROKE ON THREE DIFFERENT CLOSURE TOPS DURING FINAL TIGHTENING INTRA-OPERATIVELY. ONE OF THE BROKEN TIPS OF THE SCREWDRIVER COULD NOT BE REMOVED FROM THE CLOSURE TOP AND REMAINS IMPLANTED. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE. THIS IS REPORT THREE OF THREE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14407733 ↗InjuryMay 16, 2022Fracture; Fracture
IT WAS REPORTED THAT THE TIPS OF THREE INSTINCT JAVA SCREWDRIVERS BROKE ON THREE DIFFERENT CLOSURE TOPS DURING FINAL TIGHTENING INTRA-OPERATIVELY. ONE OF THE BROKEN TIPS OF THE SCREWDRIVER COULD NOT BE REMOVED FROM THE CLOSURE TOP AND REMAINS IMPLANTED. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE. THIS IS REPORT TWO OF THREE FOR THIS EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 14407708 ↗MalfunctionJun 18, 2020Fracture; Fracture
IT WAS REPORTED THAT DURING THE PROCEDURE THE TIP OF THE DRIVER TWISTED. NO FURTHER SURGICAL INFORMATION WAS PROVIDED AND NO REPORTED PATIENT IMPACTS. HOWEVER, DEVICE EVALUATION BY ZIMMER BIOMET PERSONNEL FOUND THE TIP OF THE DRIVER TO BE FRACTURED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10171489 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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