NA 05.000.008Recalls & reported problems
Synthes GmbH · HAND PIECE FOR BATTERY POWERED DRIVER · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes battery-powered driver handpiece is a surgical screwdriver used with skull plates. Its 382 reports mostly describe buttons, speed or power that stop working or work only intermittently, and most report no clinical effect on the patient. The reports include 1 injury and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 397
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 397 adverse event reports that list this exact device (DI 10887587024585), received between Dec 4, 2019 and Sep 28, 2026 — classified as 1 injury, 396 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (217 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem217
- Electrical /Electronic Property Problem89
- Power Problem33
- Contamination /Decontamination Problem15
- Failure to Cycle15
- Intermittent Loss of Power15
- Failure to Power Up14
- Break9
Patient problems
- No Clinical Signs, Symptoms or Conditions373
- Insufficient Information20
- No Patient Involvement2
- Fall1
- Joint Dislocation1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 397 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Mechanical Problem
It was reported that the forward speed was broken.It was noted upon manufacturers investigation that there was a foreign substance on the device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916114 ↗MalfunctionSep 24, 2026Break; Mechanical Problem
It was reported that device is broken and does not work. The issue was found during cleaning.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884020 ↗MalfunctionSep 15, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776399 ↗MalfunctionSep 15, 2026Mechanical Problem
It was reported that all speeds were broken. There was no patient involvement, the issue was identified during weekly audit.During manufactures investigation it was noted that there was a foreign substance on the device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776344 ↗MalfunctionSep 15, 2026Intermittent Loss of Power
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776290 ↗MalfunctionSep 15, 2026Mechanical Problem
It was reported that all speeds were broken. There was no patient involvement, the issue was identified during weekly audit.During manufactures investigation it was noted that there was a foreign substance on the device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776230 ↗MalfunctionSep 15, 2026Intermittent Loss of Power
It was reported that all speeds intermittently work. There was no patient involvement, the issue was identified during weekly audit.During manufactures investigation it was noted that there was a foreign substance on the device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776099 ↗MalfunctionSep 15, 2026Power Problem
It was reported that all speeds were slow. There was no patient involvement, the issue was identified during weekly audit.During manufactures investigation it was noted that there was a foreign substance on the device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776045 ↗MalfunctionSep 15, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775976 ↗MalfunctionSep 15, 2026Mechanical Problem
It was reported that a HAND PIECE FOR BATTERY POWERED DRIVER is not operating at all with battery. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50774715 ↗MalfunctionSep 15, 2026Mechanical Problem
It was found during routine testing that device stopped working. There was no patient involvement. It was reported that there was no further information regarding the issue. All available information has been disclosed. No further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50774621 ↗MalfunctionSep 15, 2026Mechanical Problem
It was found during routine testing that device stopped working. There was no patient involvement. It was reported that there was no further information regarding the issue. All available information has been disclosed.No further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50774506 ↗MalfunctionSep 15, 2026Mechanical Problem
It was reported that on an unknown date it was found during routine testing that the device stopped working. There was no patient involvement. There was no reports of injuries, medical intervention or prolonged hospitalization. It was reported that there was no further information regarding the issue. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50774387 ↗MalfunctionSep 15, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50774320 ↗MalfunctionAug 27, 2026Electrical /Electronic Property Problem
It was reported the front button not working.Problem found during routine testing. It was reported that there was no further information regarding the issue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50478732 ↗MalfunctionAug 27, 2026Power Problem
It was reported all speeds were slow. No patient involvement. It was reported that there was no further information regarding the issue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50476674 ↗MalfunctionAug 27, 2026Intermittent Loss of Power
It was reported the reverse speed intermittently works. No patient involvement. It was reported that there was no further information regarding the issue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50476225 ↗MalfunctionAug 21, 2026Power Problem
It was reported that all speeds were broken. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50369653 ↗MalfunctionAug 7, 2026Intermittent Loss of Power
It was reported that the powered driver speeds only intermittently work. There was no patient involvement. There was no reports of injuries, medical intervention or prolonged hospitalization.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50180743 ↗MalfunctionJul 31, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50101057 ↗MalfunctionJul 28, 2026Power Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50059088 ↗MalfunctionJul 28, 2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50058754 ↗MalfunctionJul 27, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50038567 ↗MalfunctionJul 27, 2026Intermittent Loss of Power
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50038419 ↗MalfunctionJul 27, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50038286 ↗
Other SCREWDRIVER, SKULLPLATE devices
- NA 03.315.700Synthes GmbH · SCREWDRIVER, SKULLPLATE1 report
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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