INSTRUMENT 6541-4-709Recalls & reported problems
Howmedica Osteonics Corp. · BOX CHISEL TRIATHLON INSTRUMENTS · Class 1
All models of INSTRUMENT (131)
Data updated Oct 18, 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 07613327179347), received between Apr 23, 2019 and Nov 15, 2020 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break2
- Crack1
- Fracture1
- Insufficient Device Problem Information1
Patient problems
- Bone Fracture(s)1
- Device Embedded In Tissue or Plaque1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 15, 2020Fracture; Fracture
TKA DUE TO RIGHT KNEE OSTEOARTHRITIS. THIS IS THE FIRST SURGERY. THE BLADE OF THE BOX CHISEL WAS CHIPPED AND THE BONE (INSIDE THE BOX) WAS SLIGHTLY SCRATCHED. THERE SEEMS TO BE NO HEALTH HAZARD. WATCH THE FUTURE PROGRESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10841561 ↗InjuryJan 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
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 9584506 ↗MalfunctionJul 1, 2019Break; Break
BOX OSTEOTOME FROM TRIATHLON SET BROKE WHILE CUTTING THE BOX. FINISHED CUT WITH SAW.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8749452 ↗MalfunctionApr 23, 2019Break; Crack; Break; Crack
PRIMARY PROCEDURE, LEFT KNEE. IT WAS REPORTED THAT DURING IMPACTION, PART OF THE BOX CHISEL BROKE OFF AND FELL INTO THE PATIENT. ALL PIECES WERE REMOVED AND PATIENT WAS IRRIGATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8541907 ↗
Other CHISEL, SURGICAL, MANUAL devices
- SIGMA 2024-85-000Depuy (Ireland) · CHISEL, SURGICAL, MANUAL63 reports
- NA 2421-01-000Depuy (Ireland) · CHISEL, SURGICAL, MANUAL36 reports
- NA 399.56Synthes GmbH · CHISEL, SURGICAL, MANUAL11 reports
- NA 399.55Synthes GmbH · CHISEL, SURGICAL, MANUAL10 reports
- T.L.I.F. 274279000Depuy Spine, LLC · CHISEL, SURGICAL, MANUAL7 reports
- NA 332.121Synthes GmbH · CHISEL, SURGICAL, MANUAL5 reports
- NA 202953Depuy Spine, LLC · CHISEL, SURGICAL, MANUAL4 reports
- GENESIS II 71440144Smith & Nephew, Inc. · CHISEL, SURGICAL, MANUAL3 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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