Instinct® Java™ System 046W1AN00641Recalls & reported problems
Zimmer Spine · Class 2
Quick summary
This Zimmer Spine Instinct Java system is used to fix spinal degeneration with pedicle screws and a screwdriver that tightens them. Most of the 29 reports describe the screwdriver tip snapping off during surgery, sometimes leaving small metal fragments in the patient, though in most cases the pieces were retrieved and the procedure finished with another instrument. One injury was reported and no deaths. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00889024342194), received between Nov 7, 2019 and Aug 29, 2022 — classified as 1 injury, 28 malfunctions.
The most frequently reported specific device problem is “Fracture” (27 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
- Fracture27
- Material Deformation1
- Material Twisted/Bent1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- No Consequences Or Impact To Patient7
- Insufficient Information3
- No Known Impact Or Consequence To Patient3
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 29 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 TWO OF TWO FOR THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 15310887 ↗MalfunctionApr 22, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING THE SURGERY, A FINAL DRIVER STRIPPED. HOWEVER, DEVICE EVALUATION BY THE MANUFACTURER FOUND THE TIP HAD FRACTURED OFF. A SECOND DRIVER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT IMPACTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14186856 ↗MalfunctionMar 8, 2022Fracture; Fracture
IT WAS REPORTED THAT ONE INSTINCT FINAL DRIVER WAS RETURNED FROM A HOSPITAL WITH THE TIP FRACTURED OFF; THE TIP WAS NOT RETURNED. THE SPECIFIC SURGICAL OR PATIENT INFORMATION IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 13686237 ↗MalfunctionNov 17, 2021Fracture; Fracture
IT WAS REPORTED THAT THE TIPS OF THREE FINAL DRIVERS BROKE OFF IN A BLOCKER INTRA-OPERATIVELY. THE TIPS WERE RECOVERED AND THE PROCEDURE WAS COMPLETED USING ANOTHER FINAL DRIVER. THERE WERE NO REPORTED PATIENT IMPACTS. THIS IS REPORT THREE OF THREE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12828298 ↗MalfunctionNov 17, 2021Fracture; Fracture
IT WAS REPORTED THAT THE TIPS OF THREE FINAL DRIVERS BROKE OFF IN A BLOCKER INTRA-OPERATIVELY. THE TIPS WERE RECOVERED AND THE PROCEDURE WAS COMPLETED USING ANOTHER FINAL DRIVER. THERE WERE NO REPORTED PATIENT IMPACTS. THIS IS REPORT TWO OF THREE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12828281 ↗MalfunctionNov 17, 2021Fracture; Fracture
IT WAS REPORTED THAT THE TIPS OF THREE FINAL DRIVERS BROKE OFF IN A BLOCKER INTRA-OPERATIVELY. THE TIPS WERE RECOVERED AND THE PROCEDURE WAS COMPLETED USING ANOTHER FINAL DRIVER. THERE WERE NO REPORTED PATIENT IMPACTS. THIS IS REPORT ONE OF THREE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12828279 ↗MalfunctionNov 7, 2021Fracture; Fracture
IT WAS REPORTED THE TIPS OF TWO FINAL SCREWDRIVER SHAFTS BROKE INTRA-OPERATIVELY WHILE FINAL TIGHTENING THE BLOCKERS. THE FRAGMENTS WERE RECOVERED AND THE PROCEDURE WAS COMPLETED USING ANOTHER FINAL DRIVER SHAFT WITHOUT PATIENT IMPACTS. THIS IS REPORT THREE OF THREE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12761629 ↗MalfunctionNov 7, 2021Fracture; Fracture
IT WAS REPORTED THE TIPS OF TWO FINAL SCREWDRIVER SHAFTS BROKE INTRA-OPERATIVELY WHILE FINAL TIGHTENING THE BLOCKERS. THE FRAGMENTS WERE RECOVERED AND THE PROCEDURE WAS COMPLETED USING ANOTHER FINAL DRIVER SHAFT WITHOUT PATIENT IMPACTS. THIS IS REPORT TWO OF THREE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12761612 ↗MalfunctionNov 7, 2021Fracture; Fracture
IT WAS REPORTED THE TIPS OF TWO FINAL SCREWDRIVER SHAFTS BROKE INTRA-OPERATIVELY WHILE FINAL TIGHTENING THE BLOCKERS. THE FRAGMENTS WERE RECOVERED AND THE PROCEDURE WAS COMPLETED USING ANOTHER FINAL DRIVER SHAFT WITHOUT PATIENT IMPACTS. THIS IS REPORT ONE OF THREE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12761532 ↗MalfunctionJul 9, 2021Fracture; Fracture
IT WAS REPORTED THAT THE TIP WAS FOUND TO HAVE FRACTURED OFF A DRIVER AFTER BEING RETURNED FROM A HOSPITAL. NO INFORMATION HAS BEEN PROVIDED BY THE HOSPITAL IN ASSOCIATION WITH THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 12143606 ↗MalfunctionJun 7, 2021Fracture; Fracture
IT WAS REPORTED THAT DURING FINAL TIGHTENING THE TIP OF THE SCREWDRIVER BROKE OFF. THE BROKEN PIECE WAS RETRIEVED. ANOTHER SCREWDRIVER WAS USED TO COMPLETE THE CASE. THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11950839 ↗MalfunctionMay 17, 2021Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE FINAL SCREWDRIVER FRACTURED INTRA OPERATIVELY. THE TIP WAS RETRIEVED. THERE WAS NO REPORTED IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11832603 ↗MalfunctionApr 27, 2021Fracture; Fracture
IT WAS REPORTED THAT DURING FINAL TIGHTENING IN SURGERY, TWO FINAL SCREWDRIVERS' TIPS BROKE OFF. THE TIPS WERE RETRIEVED. A THIRD DRIVER WAS USED TO COMPLETE THE CASE. THERE WAS NO REPORTED IMPACT ON THE PATIENT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11734883 ↗MalfunctionApr 27, 2021Fracture; Fracture
IT WAS REPORTED THAT DURING FINAL TIGHTENING IN SURGERY, TWO FINAL SCREWDRIVERS' TIPS BROKE OFF. THE TIPS WERE RETRIEVED. A THIRD DRIVER WAS USED TO COMPLETE THE CASE. THERE WAS NO REPORTED IMPACT ON THE PATIENT. THIS IS REPORT ONE OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11734829 ↗MalfunctionApr 12, 2021Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE FINAL DRIVER FRACTURED WHILE TIGHTENING A BLOCKER. THE BROKEN TIP WAS RETRIEVED FROM THE BLOCKER AN ANOTHER DRIVER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11648397 ↗MalfunctionApr 6, 2021Fracture; Fracture
IT WAS REPORTED THAT A FINAL DRIVER FRACTURED DURING USE. THE FRACTURED FRAGMENT WAS RETRIEVED AND DISCARDED AND ANOTHER DRIVER WAS USED TO COMPLETE THE SURGERY. THERE WAS NO IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11619090 ↗MalfunctionApr 5, 2021Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF A DRIVER FRACTURED DURING AN OPERATION THE DOCTOR USED ANOTHER OF THE SAME TYPE OF INSTRUMENT TO COMPLETE THE OPERATION. THERE WAS NO REPORTED EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11614650 ↗MalfunctionMar 26, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT A FINAL DRIVER WAS WORN DURING SURGERY. HOWEVER, THE TIP WAS FOUND TO HAVE FRACTURE OFF WHEN THE DEVICE WAS EVALUATED BY THE MANUFACTURER. ANOTHER DRIVER WAS USED TO COMPLETE THE SURGERY WITHOUT PATIENT IMPACTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11574810 ↗MalfunctionFeb 9, 2021Fracture; Fracture
IT WAS REPORTED THAT A SCREWDRIVER WAS FRACTURED DURING FINAL TIGHTENING WITHIN SURGERY. THE SECOND SCREWDRIVER IN THE SET WAS USED TO COMPLETE THE OPERATION. THERE WAS NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11303611 ↗MalfunctionFeb 9, 2021Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF A FINAL SCREWDRIVER SHAFT FRACTURED AT THE END OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DRIVER. THERE WAS NO IMPACT ON THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11303542 ↗MalfunctionFeb 9, 2021Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF A FINAL DRIVER BROKE OFF DURING SURGERY. ANOTHER DRIVER WAS USED TO COMPLETE THE PROCEDURE WITHOUT REPORTED PATIENT IMPACTS
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11303206 ↗MalfunctionNov 10, 2020Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF A JAVA INSTINCT SCREWDRIVER SHAFT FRACTURED DURING SURGERY. ALL PARTS WERE RETRIEVED BY THE SURGEON AND THERE WAS NO REPORTED PATIENT HARM OR INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10817249 ↗MalfunctionOct 21, 2020Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF A FINAL DRIVER FRACTURED DURING SURGERY. AN ALTERNATIVE DRIVER WAS USED TO COMPLETE THE PROCEDURE WITHOUT REPORTED PATIENT IMPACTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10714497 ↗MalfunctionOct 13, 2020Fracture; Fracture
IT WAS FURTHER REPORTED THAT THERE WAS A FIFTEEN MINUTE DELAY AND THAT IT IS UNKNOWN IF THE PATIENT RETAINED THE TIPS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10673680 ↗MalfunctionOct 13, 2020Fracture; Fracture
IT WAS FURTHER REPORTED THAT THERE WAS A FIFTEEN MINUTE DELAY AND THAT IT IS UNKNOWN IF THE PATIENT RETAINED THE TIPS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10673671 ↗
Other Orthosis, spinal pedicle fixation, for degenerative disc disease devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.