Spine Instruments 03.51.10.0136Recalls & reported problems
Medacta International SA · Polyaxial Screwdriver- Slim Design · Class 1
All models of Spine Instruments (28)
Data updated Oct 18, 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 07630971201620), received between May 3, 2019 and Oct 30, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Material Fragmentation1
Patient problems
- Device Embedded In Tissue or Plaque1
- 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.
MalfunctionOct 30, 2025Fracture; Fracture
DURING INSERTION OF A 6X45MM SCREW IN S1 THE TIP OF THE SCREWDRIVER BROKE INSIDE THE SCREW HEAD. SURGEON USED A TULIP AND A 35MM ROD TO EXTRACT THE SCREW. BACKUP SCREW (6X45MM) AND SCREWDRIVER WERE USED TO COMPLETE THE SURGERY. 30 MINUTES OF DELAY REPORTED OVER 2H30 OF SURGERY TIME. BONE QUALITY WAS REPORTED TO BE NORMAL. STANDARD TAPPING WAS PERFORMED, 6MM (GREEN COLORED).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23424080 ↗MalfunctionMay 3, 2019Material Fragmentation; Material Fragmentation
DURING THE SURGERY, THE TIP OF THE SCREWDRIVER GOT BROKEN. THE SURGEON INSERTED A SCREW AND THEN ONE OF THE "WINGS" OF THE TIP OF THE SCREWDRIVER GOT BROKEN. THE SURGERY ENDED SUCCESSFULLY, BUT THE SURGEON WASN'T ABLE TO REMOVE THE BROKEN TIP OF THE INSTRUMENT OUT OF THE SCREW. THE BROKEN TIP STILL STICKS IN THE SCREW AND IS IMPLANTED IN THE PATIENT. BUT IT COULDN'T HARM THE PATIENT, BECAUSE IT'S LOCKED WITH THE ROD AND SET SCREW. ANOTHER MEDACTA SCREWDRIVER HAS BEEN USED TO FINISH THE SURGERY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8577869 ↗
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- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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