INSTRUMENT 7650-1956Recalls & reported problems
Howmedica Osteonics Corp. · PASSPORT KNEE INSTRUMENTATION PROXIMAL ROD · Class 1
All models of INSTRUMENT (131)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327234022), received between Jun 12, 2018 and Apr 22, 2020 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 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 16, 2026.
Most reported problems
Device problems
- Fracture4
- Break2
Patient problems
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2020Fracture; Fracture
IT WAS REPORTED THAT THE PROXIMAL ROD ASSEMBLY SPIKE PART OF THE PPTD INSTRUMENT WAS DAMAGED AT THE TIME OF DRIVING AND REMAINED INSIDE THE FEMUR. IT WAS FOUND ON THE X-RAY AFTER THE OPERATION. WHEN CHECKING FOR DAMAGE BEFORE CLEANING THE INSTRUMENT, IT WAS DISCOVERED THAT THERE WAS NO SPIKE PART.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9986029 ↗MalfunctionJan 15, 2019Fracture; Fracture
DURING THE OPERATION, A PART TO BE DRIVEN INTO THE TIBIAL PLATEAU IN THE PROXIMAL PART OF THE PRODUCT WAS BROKEN. THE DEBRIS HAS BEEN COLLECTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8250596 ↗MalfunctionOct 24, 2018Break; Fracture; Break; Fracture
IT WAS REPORTED THAT WHEN THE FIXED PIN OF THE PROXIMAL ROD ASSEMBLY WAS HIT IN THE BONE, THE PIN WAS BROKEN. THE ALL BROKEN PART WAS REMOVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8002396 ↗InjuryJun 12, 2018Break; Fracture; Break; Fracture
IT WAS REPORTED THAT WHEN THE FIXED PIN OF THE PROXIMAL ROD ASSEMBLY WAS HIT IN THE BONE, THE PIN WAS BROKEN. THE ALL BROKEN PART WAS REMOVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7591509 ↗
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- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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