TwinLoop FLEX 3910-400-100Recalls & reported problems
Stryker Corporation · TWINLOOP FLEX DISPOSABLE DRILL · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540678225), received between Dec 16, 2020 and Oct 24, 2025 — classified as 2 injuries, 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Material Fragmentation2
Patient problems
- Foreign Body In Patient2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 24, 2025Break; Material Fragmentation; Break; Material Fragmentation
IT WAS REPORTED THAT A PATIENT UNDERGOING ARTHROSCOPIC SHOULDER SURGERY EXPERIENCED A BROKEN DRILL BIT WHICH REMAINED LODGED INTRAOSSEOUSLY.
Patient problems: Foreign Body In Patient
MAUDE report 23382307 ↗InjuryOct 24, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT A PATIENT UNDERGOING ARTHROSCOPIC SHOULDER SURGERY EXPERIENCED A BROKEN DRILL BIT WHICH REMAINED LODGED INTRAOSSEOUSLY.
Patient problems: Foreign Body In Patient
MAUDE report 23382281 ↗MalfunctionDec 16, 2020Break
IT WAS REPORTED THAT THE TIP OF THE DRILL BROKE DURING THE PROCEDURE. THE TIP WAS RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11016233 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.