UNIUMRecalls & reported problems across all models
Synthes GmbH · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 353
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 3 models of UNIUM by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 353 adverse event reports in the FDA's MAUDE database, received between Jan 18, 2022 and Sep 30, 2026 — classified as 353 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (137 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported UNIUM problems
Device problems
- Physical Resistance/Sticking137
- Device Slipped64
- Intermittent Loss of Power58
- Complete Loss of Power54
- Output below Specifications35
- Mechanical Jam34
- Detachment of Device or Device Component32
- Appropriate Device Problem Term/Code Not Available29
Patient problems
- No Clinical Signs, Symptoms or Conditions353
UNIUM models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- UNIUM 05.001.601INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT339 reports
- UNIUM 05.001.188INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT12 reports
- UNIUM 05.001.611INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT2 reports
Recent UNIUM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break; Detachment of Device or Device Component
It was reported that the coupling of the handpiece device was defective. During in-house engineering evaluation it was determined that the protective heat cover fell off the handpiece and was missing. This event did not occur during surgery. There were no reports of injuries, medical intervention, or prolonged hospitalization. The exact date of the event was not reported; however, it was reported that the event occurred in 2026. All available information has been disclosed. If additional information should become available, a Supplemental MedWatch will be submitted accordingly.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951778 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951278 ↗MalfunctionSep 28, 2026Component Missing
It was reported that during service and evaluation, it was determined that the modular handpiece device had missing components. It was noted in the service order that the device was missing a ring. This event did not occur during surgery. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. However, it was reported that the event occurred in 2026. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914843 ↗MalfunctionSep 28, 2026Component Missing
It was reported that during service and repair pre-testing, it was discovered that the modular handpiece device had missing components. This event did not occur during surgery. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. However, it was reported that the event occurred in 2026. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914674 ↗MalfunctionSep 21, 2026Noise, Audible; Intermittent Loss of Power
It was reported that the oscillating function of the handpiece device continued to operate intermittently after use, accompanied by abnormal noise. It was not reported if the device was used in a surgical procedure. There was no human patient involvement as this was a veterinary procedure. There were no reports of injuries, medical intervention, or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a Supplemental MedWatch will be submitted accordingly.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50838549 ↗MalfunctionSep 18, 2026Unintended System Motion
It was reported that during an unspecified surgery, the oscillation mode on the UNIUM¿ MODULAR HANDPIECE device would partially activate when activated normally. There was no delay in the procedure reported. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50823783 ↗MalfunctionSep 18, 2026Device Slipped
It was reported that while using the UNIUM MODULAR HANDPIECE device, when a command was activated on the equipment it triggered a different command. It was not reported if the device was used in surgery. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50818717 ↗MalfunctionSep 17, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810110 ↗MalfunctionSep 17, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808658 ↗MalfunctionSep 17, 2026Noise, Audible; Intermittent Loss of Power
It was reported that during pre-surgery testing it was observed that, after attaching the K-wire attachment to the handpiece device, there was a metal grinding noise during operation. It was further observed that the handpiece device briefly stopped working and then automatically resumed working. It was reported that there was no delay in the procedure due to the event. There were no reports of injuries, medical There were no reports of injuries, medical intervention, or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a Supplemental MedWatch will be submitted accordingly.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802114 ↗MalfunctionSep 16, 2026Physical Resistance/Sticking
It was reported that during product maintenance it was observed that the reverse button on the handpiece device could not be completely pressed. This event did not occur during a surgical procedure. There were no reports of injuries, medical intervention, or prolonged hospitalization. The exact date of the event was not reported; however, it was reported that the event occurred in 2026. All available information has been disclosed. If additional information should become available, a Supplemental MedWatch will be submitted accordingly.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787248 ↗MalfunctionSep 15, 2026Break; Mechanical Jam; Physical Resistance/Sticking
It was reported that during an unspecified surgical procedure it was observed that the upper trigger of the handpiece device was broken, and the reverse mode could not be used. It was reported that the upper trigger would not fully press down, making it difficult to use the reverse function. There were no reports of injuries, medical intervention, or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a Supplemental MedWatch will be submitted accordingly.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50770971 ↗MalfunctionSep 14, 2026Unintended System Motion; Appropriate Device Problem Term/Code Not Available; Intermittent Loss of Power
It was reported that during testing, the UNIUM MODULAR HANDPIECE device trigger pulled on its own. What happened was that the oscillate function would activate on its own, very intermittently. There was a problem with the seals in the triggers. This event did not occur during surgery. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50754465 ↗MalfunctionSep 11, 2026Intermittent Loss of Power
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50740665 ↗MalfunctionSep 3, 2026Intermittent Loss of Power
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50595114 ↗
Other Synthes GmbH products
All Synthes GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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