INSTRUMENT 6633-7-736Recalls & reported problems
Howmedica Osteonics Corp. · ASSEMBLY MONOGRAM INSTR SLOTTED PATELLAR RESECTION GUIDE · Class 1
All models of INSTRUMENT (131)
Data updated Oct 16, 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 07613327230253), received between Mar 26, 2019 and Mar 26, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Bone Fracture(s)1
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
DURING A DIFFICULT PRIMARY KNEE REPLACEMENT, THE SURGEON HAD TROUBLE RETRACTING THE TIBIA ANTERIORALLY DUE TO A TIGHT PATELLA TENDON; THE RESULT OF A PRIOR TIBIAL FRACTURE. WHEN THE PATELLA WAS RESSECTED, IT FRACTURED. TWO 4MM X36MM CANNULATED SCREWS WERE USED TO FIX THE FRACTURE. SOME THREADS OF THE SCREWS WERE VISIBLE THROUGH THE SURFACE WHERE THE BONE CEMENT WAS TO BE APPLIED. THE PATELLA WAS IMPLANTED AND SURGERY CONTINUED AS PLANNED.
Patient problems: Bone Fracture(s); Injury
MAUDE report 8451467 ↗
Other Guide, surgical, instrument devices
- NA 03.037.017Synthes GmbH · Guide, surgical, instrument346 reports
- EVOS 71174934Smith & Nephew, Inc. · Guide, surgical, instrument149 reports
- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
- DJO SURGICAL 342-10-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall51 reports
- DJO SURGICAL 341-10-707Encore Medical, L.P. · Guide, Surgical, Instrument81 reports
- NA 03.010.404Synthes GmbH · Guide, surgical, instrument73 reports
- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
- DJO SURGICAL 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 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.
How reports and recalls are matched · Editorial policy · Report an error on this page