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INSTRUMENT 6541-5-713Recalls & reported problems

Howmedica Osteonics Corp. · MIS BOX GUIDE TRIATHLON MIS INSTRUMENTS · Class 2

All models of INSTRUMENT (131)

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 07613327242737), received between Jan 13, 2020 and Jan 13, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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

  • Fracture1

Patient problems

  • Bone Fracture(s)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 13, 2020Fracture; Fracture

    PRIMARY PROCEDURE, LEFT KNEE. IT WAS REPORTED THAT AFTER USING THE PS BOX GUIDE AND CHISEL, A CRACK IN THE PATIENT'S MEDIAL CONDYLE WAS NOTED. THE FRACTURE WAS ADDRESSED USING A K-WIRE, AND THE SURGERY WAS COMPLETED WITH NO DELAY. THE REP REPORTED THAT THE DEVICES WILL BE KEPT IN USE BY THE HOSPITAL, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: Bone Fracture(s)

    MAUDE report 9584513 ↗

Other PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices →

Sources and updates

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