INSTRUMENT I-K2958TI00Recalls & reported problems
Howmedica Osteonics Corp. · SPECIALTY TRIATHLON PKR C-ARM TIBIAL IMPACTOR · Class 1
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 07613327258318), received between Oct 14, 2020 and Oct 14, 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
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 14, 2020Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information
THE WELDED PART AT THE TIP OF "I-K2958TI00" IN THE AT PKR-RM-LL INSTRUMENT SET WAS REMOVED AND IT WAS INSIDE THE JOINT. IT WAS DISCOVERED AT THE TIME OF POSTOPERATIVE X-RAY CONFIRMATION. A SKIN INCISION WAS MADE AGAIN AND IT WAS REMOVED FROM THE JOINT. THERE IS NO RESIDUE IN THE BODY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 10677372 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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