INSTRUMENT I-K27280809Recalls & reported problems
Howmedica Osteonics Corp. · SPECIALTY TRIATHLON PKR UNIVERSAL INSERT TRIAL 8mm-9mm · Class 1
All models of INSTRUMENT (131)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327305913), received between Dec 26, 2018 and Apr 27, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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 16, 2026.
Most reported problems
Device problems
- Fracture2
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 27, 2021Fracture; Fracture
FILLER GAUGE CRACKED WHEN IT WAS USED FOR CHECKING THE TENSION BEFORE THE FINAL INSERT SELECTION. BROKEN PART FIT PERFECTLY, SO INSERT WAS PLACED AFTER CLEANING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11730574 ↗MalfunctionDec 26, 2018Crack; Fracture; Crack; Fracture
IT BROKE WHEN DR TRIED TO PULL OUT AFTER INSERTING THE INSERT TRIAL. THE NURSE CONFIRMED WHETHER ALL BROKEN PARTS WERE COLLECTED OR NOT. AFTER CONFIRMING THAT ALL DEBRIS WAS REMOVED FROM THE PATIENT'S BODY, THE OPERATION WAS CONTINUED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8195618 ↗
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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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