INSTRUMENT 5650-4-512ARecalls & reported problems
Howmedica Osteonics Corp. · PEG DRILL SIZE 1-2 TRIATHLON PKR INSTRUMENTS · 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 07613327252309), received between Sep 11, 2019 and Sep 11, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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
- Device Difficult to Setup or Prepare1
- Inadequacy of Device Shape and/or Size1
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.
InjurySep 11, 2019Device Difficult to Setup or Prepare; Inadequacy of Device Shape and/or Size; Device Difficult to Setup or Prepare; Inadequacy of Device Shape and/or Size
(B)(6) 2019 KNEE JOINT REPLACEMENT DID. (B)(6) 2019,THE PATIENT COMPLAINED OF PAIN AND HAD A FRACTURE IN THE TIBIA. AT FIRST, DR. DECIDED THAT IT WAS A TECHNICAL PROBLEM, BUT THERE WAS A FRACTURE STARTING FROM THE EXTENSION OF THE INNER PEG. # 2 HAD THE SAME LENGTH AS THE PEG # 3, # 1 AND # 2 ARE TOO LONG. THERE ARE NO REVISIONS, ETC., AND FOLLOW- UP IS IN PROGRESS.
Patient problems: Bone Fracture(s); Injury
MAUDE report 8994515 ↗
Other BIT, DRILL devices
- QUICKSET 2274-25-500Depuy Orthopaedics, Inc. · BIT, DRILL1,985 reports
- QUICKSET 2274-35-500Depuy Orthopaedics, Inc. · BIT, DRILL770 reports
- QUICKSET 2274-30-500Depuy Orthopaedics, Inc. · BIT, DRILL761 reports
- NA 03.037.022Synthes GmbH · BIT, DRILL339 reports
- NA 323.062Synthes GmbH · BIT, DRILL309 reports
- QUICKSET 2274-56-000Depuy (Ireland) · BIT, DRILL275 reports
- QUICKSET 2274-45-500Depuy Orthopaedics, Inc. · BIT, DRILL211 reports
- LCS 2366-83-000Depuy (Ireland) · BIT, DRILL207 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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