N/A DK-200CRecalls & reported problems
Synthes GmbH · Speed 2.0mm Instrument Kit Comprehensive · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810633022085), received between Mar 29, 2024 and Aug 4, 2025 — classified as 3 malfunctions.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Entrapment of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 4, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE STAPLES PRE DEPLOYED BEFORE PULLING / PUSHING BUTTON, SURGEON DID NOT WANT ANYTHING TO BE CHARGED. THE MULTIFUNCTION TOOL DID NOT THREAD, SD 2.5 HEX WAS WARPED (SD314.001).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22709830 ↗MalfunctionAug 4, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE STAPLES PRE DEPLOYED BEFORE PULLING / PUSHING BUTTON, SURGEON DID NOT WANT ANYTHING TO BE CHARGED. THE MULTIFUNCTION TOOL DID NOT THREAD, SD 2.5 HEX WAS WARPED (SD314.001).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22709746 ↗MalfunctionMar 29, 2024Entrapment of Device; Entrapment of Device
IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A FOOT SURGERY WITH THE SYNTHES TRIAD FIXATION INSTRUMENT. POST OPERATIVE FINDINGS HAD SHOWN THAT THE PATIENT HAD AN ADDITIONAL METALLIC DENSITY. AFTER ADDITIONAL SCREENING, CT FINDINGS INDICATED THAT THE METALLIC DENSITY WAS IN THE SOFT TISSUE AND MEASURED UP TO 2 CM IN LENGTH. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SPEED 2.0MM INSTRUMENT KIT COMPREHENSIVE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 19002537 ↗
Other Kit, Surgical Instrument, Disposable devices
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- Synergetics 18061Synergetics USA, Inc. · Kit, Surgical Instrument, Disposable2 recalls0 reports
- Medline Industries, Inc. DYNJ83185AMedline Industries, Inc. · Kit, surgical instrument, disposable2 recalls0 reports
- Synergetics 18069Synergetics USA, Inc. · Kit, Surgical Instrument, Disposable2 recalls0 reports
- Medline Industries, Inc. DYNJ69761Medline Industries, Inc. · Kit, surgical instrument, disposable2 recalls0 reports
- Medline Industries, Inc. DYNJ24628MMedline Industries, Inc. · Kit, surgical instrument, disposable2 recalls0 reports
- Synergetics 18060Synergetics USA, Inc. · Kit, Surgical Instrument, Disposable2 recalls0 reports
- Synergetics 18069WSynergetics USA, Inc. · Kit, Surgical Instrument, Disposable2 recalls0 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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