NA 111160Recalls & reported problems
Mako Surgical Corp. · SQUARE DRIVER · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00848486002763), received between Oct 30, 2019 and Dec 2, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Misassembly by Users” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Misassembly by Users2
- Crack1
- Mechanical Problem1
Patient problems
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 2, 2019Misassembly by Users; Misassembly by Users
SCREW DRIVER IS CROSS THREADED. CASE TYPE: TKA. PATIENT WAS UNDER ANESTHESIA.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9396890 ↗MalfunctionNov 26, 2019Misassembly by Users; Misassembly by Users
SILVER END OF SQUARE DRIVER CAME LOOSE FROM THE BLUE HANDLE WHILE TAKING APART ARRAYS/ARRAY CLAMPS. CASE TYPE: PKA (ANSPACH). SURGICAL DELAY: > 30 MINUTES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9378968 ↗MalfunctionOct 30, 2019Crack; Mechanical Problem; Crack; Mechanical Problem
THE HANDLE ON THE MICS/ARRAY WRENCH BECAME LOOSE UPON DISASSEMBLING THE ARRAYS. CASE TYPE: TKA. SURGICAL DELAY : YES > 30 MINUTES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9258402 ↗
Other Orthopedic stereotaxic instrument devices
- REAL INTELLIGENCE ROB10024Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall924 reports
- NA 209063Mako Surgical Corp. · Orthopedic stereotaxic instrument2 recalls602 reports
- RESTORIS, RIO 212760Mako Surgical Corp. · Orthopedic stereotaxic instrument605 reports
- REAL INTELLIGENCE ROB10013Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall528 reports
- VELYS 4515-70-105Depuy (Ireland) · Orthopedic stereotaxic instrument578 reports
- VELYS 4515-70-106Depuy (Ireland) · Orthopedic stereotaxic instrument564 reports
- NA 209999Mako Surgical Corp. · Orthopedic stereotaxic instrument522 reports
- Mazor X System TPL0059-06Mazor Robotics Ltd · Orthopedic Stereotaxic Instrument2 recalls2 deaths392 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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