Spine Instruments 03.51.10.0240Recalls & reported problems
Medacta International SA · Cannulated Tap Tapered Tip Ø6mm undersized 0.5mm · 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 07630971230934), received between Apr 26, 2019 and Aug 23, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Material Fragmentation2
Patient problems
- Foreign Body In Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 23, 2019Material Fragmentation; Material Fragmentation
DURING SURGERY THE CANNULATED TIP OF THE INSTRUMENT PARTIALLY BROKE. THE FRAGMENT WAS NOT FOUND IN THE SURGERY ROOM. THE FLUOROSCOPY DIDN'T SHOW THE PRESENCE OF THE PIECE IN THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8924579 ↗MalfunctionApr 26, 2019Material Fragmentation; Material Fragmentation
TIP BREAKAGE OF TWO CANNULATED TAPERED TAPS UNDERSIZED WHEN THE SURGEON WAS TAPPING AT L4/5. THE PATIENT BONE WAS HARD. THE TIPS REMAINED IN THE PATIENT BUT DEEP ENOUGH, THE PEDICLE SCREWS WERE INSERTED WITH NO PROBLEM OF IMPINGEMENT. 30 MINUTES OF DELAY.
Patient problems: Foreign Body In Patient
MAUDE report 8555119 ↗
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 18, 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