NA 393.76Recalls & reported problems
Synthes GmbH · OPEN COMPRESSOR · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982199430), received between Jan 11, 2023 and Jan 11, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 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.
Most reported problems
Device problems
- Break4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 11, 2023Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE REPORTED PRODUCTS WERE BROKEN/DAMAGED. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT IS FOR ONE (1)OPEN COMPRESSOR. THIS IS REPORT 7 OF 7 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16137124 ↗MalfunctionJan 11, 2023Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE REPORTED PRODUCTS WERE BROKEN/DAMAGED. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT IS FOR ONE (1)OPEN COMPRESSOR. THIS IS REPORT 6 OF 7 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16137122 ↗MalfunctionJan 11, 2023Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE REPORTED PRODUCTS WERE BROKEN/DAMAGED. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT IS FOR ONE (1)OPEN COMPRESSOR. THIS IS REPORT 5 OF 7 FOR COMPLAINT: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16137118 ↗MalfunctionJan 11, 2023Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE REPORTED PRODUCTS WERE BROKEN/DAMAGED. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT IS FOR ONE (1)OPEN COMPRESSOR. THIS IS REPORT 4 OF 7 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16137114 ↗
Other APPARATUS, TRACTION, NON-POWERED devices
- Arthrex® AR-1600MArthrex, Inc. · Apparatus, traction, non-powered21 reports
- Active Heel Traction Boot 72203270Smith & Nephew, Inc. · APPARATUS, TRACTION, NON-POWERED20 reports
- NA 357.371Synthes GmbH · APPARATUS, TRACTION, NON-POWERED16 reports
- NA SD393.640Synthes GmbH · APPARATUS, TRACTION, NON-POWERED15 reports
- NA 394.44Synthes GmbH · APPARATUS, TRACTION, NON-POWERED12 reports
- Active Heel Traction Boot 72202682Smith & Nephew, Inc. · APPARATUS, TRACTION, NON-POWERED10 reports
- Arthrex® AR-8970JDArthrex, Inc. · Apparatus, traction, non-powered10 reports
- NA 72201725Smith & Nephew, Inc. · APPARATUS, TRACTION, NON-POWERED8 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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