Spine Instruments 03.51.10.0622Recalls & reported problems
Medacta International SA · MUST 2.0 Screwdriver · Class 1
All models of Spine Instruments (28)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630971267015), received between Nov 21, 2025 and Nov 21, 2025 — classified as 1 malfunction.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 21, 2025Fracture; Fracture
DURING SPINE SURGERY IN L5-S1 WHILE INSERTING A SCREW IN L5 THE TIP OF THE SCREWDRIVER BROKE. NO TAP WAS PERFORMED. BROKEN TIP WAS RECOVERED AND SCREW POSITION WAS CONSIDERED ALREADY GOOD. A BACKUP SCREWDRIVER WAS USED TO COMPLETE THE SURGERY. MOREOVER, DURING PREPARATION OF THE S1 LEFT TRAJECTORY, THE LENKE PROBE BROKE; THE BROKEN PART WAS LEFT IN THE PATIENT, DUE TO THE IMPOSSIBILITY TO REMOVE IT. NO HAMMERING, BENDING OR FLEXING OF THE PROBE WAS REPORTED. THE REPORTED ISSUES CAUSED A 30 MINUTE DELAY OVER A 3H SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23615341 ↗
Other Orthopedic Manual Surgical Instrument devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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