NA 03.010.137Recalls & reported problems
Synthes GmbH · LONG COMPRESSION DEVICE FOR TI CANNULATED TIBIAL NAILS-EX · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982067944), received between Jan 18, 2019 and Jan 18, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).
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.
Most reported problems
Device problems
- Device-Device Incompatibility1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 18, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2018, BEFORE THE SURGERY ON TITANIUM CANNULATED TIBIAL NAILS EXPERT NAILING SYSTEM, THE SCRUB TECHNICIAN OPENED THE TIBIAL NAIL EXPERT SET. IT WAS NOTICED THAT THE CANNULATED CONNECTING SCREW HAD THE LONG COMPRESSION DEVICE MECHANISM INCARCERATED WITHIN THE SCREW. THEY COULD SEPARATE THE TWO. THEY USED ANOTHER CONNECTING SCREW. PATIENT WAS NOT IN THE ROOM WHEN IT WAS NOTICED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) COMPRESSION DEVICE. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8262320 ↗
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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page