Tornier Flex MWF603SRecalls & reported problems
Tornier · Standard Stem+ Compactor · Class 1
Data updated Oct 13, 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 03700386977145), received between Jun 28, 2022 and Nov 17, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Residue After Decontamination” (3 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
- Residue After Decontamination3
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
- Limb Fracture1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 17, 2025Residue After Decontamination; Residue After Decontamination
UPON INSPECTION OF TRAY AT WAREHOUSE, BLOOD/BONE FOUND INSIDE INSTRUMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23575400 ↗MalfunctionNov 4, 2025Residue After Decontamination; Residue After Decontamination
IT WAS REPORTED THAT, UPON INSPECTION AT THE WAREHOUSE, BLOOD RESIDUE WAS OBSERVED INSIDE THE INSTRUMENTS ASSOCIATED WITH THE TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23465070 ↗MalfunctionOct 31, 2025Residue After Decontamination; Residue After Decontamination
UPON INSPECTION OF TRAY AT WAREHOUSE, BLOOD WAS FOUND INSIDE INSTRUMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23441362 ↗InjuryJun 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS IMPLANTED WITH A REVERSE SHOULDER PROTHESIS. DURING THE PROCEDURE WHILE USING THE ASCEND FLEX COMPACTORS, AN UNPLANNED HUMERAL FRACTURE OCCURRED. THE EVENT WAS RESOLVED WITHOUT SEQUALAE.
Patient problems: Limb Fracture
MAUDE report 14848334 ↗
Other INSTRUMENT, COMPRESSION devices
- ATTUNE 2545-01-042Depuy (Ireland) · INSTRUMENT, COMPRESSION153 reports
- ATTUNE 2545-11-041Depuy (Ireland) · INSTRUMENT, COMPRESSION78 reports
- ATTUNE 2545-05-550Depuy (Ireland) · INSTRUMENT, COMPRESSION54 reports
- ATTUNE 2545-05-551Depuy (Ireland) · INSTRUMENT, COMPRESSION34 reports
- NA 03.111.021Synthes GmbH · INSTRUMENT, COMPRESSION32 reports
- ATTUNE 2545-05-552Depuy (Ireland) · INSTRUMENT, COMPRESSION27 reports
- NA 03.211.400Synthes GmbH · INSTRUMENT, COMPRESSION25 reports
- VIPER PRIME 286750083Medos International Sàrl · INSTRUMENT, COMPRESSION18 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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