Knee Instruments 02.18.10.0031Recalls & reported problems
Medacta International SA · Connector for distal spacer · Class 1
All models of Knee Instruments (33)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630040782524), received between Nov 6, 2019 and Nov 6, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Device Fell” (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.
Most reported problems
Device problems
- Device Fell1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 6, 2019Device Fell
DURING THE PRIMARY KNEE SURGERY, AND WHILE THE SURGEON GRABBED THE CONNECTOR ROD TO MAKE A FEMORAL CUT, THE CONNECTOR ROD DROPPED OUT OF HIS HANDS AND FELL. THE SURGEON ASKED FOR ANOTHER CONNECTOR ROD WHICH WAS NOT AVAILABLE. THE CONNECTOR ROD HAD TO BE FLASHED FOR 24 MINUTES TO BE USED IN THE SURGERY. THERE WAS A 24- MINUTE DELAY IN THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Code Available
MAUDE report 9284064 ↗
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.
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