Skip to content

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

All INSTRUMENT, COMPRESSION devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page