NA 338.720Recalls & reported problems
Synthes GmbH · 4.5MM/2.0MM INSERT WIRE SLEEVE 93MM · Class 1
- 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 10886982193575), received between Jun 20, 2025 and Jun 20, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 20, 2025Break; Break
IT WAS REPORTED THAT THE SURGEON WAS CUTTING A LARGE EXTERNAL FIXATION SCHANZ SCREW 5.0 MM DIAMETER AND THE TIP OF THE CUTTER BROKE. FRAGMENTS WERE GENERATED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. SURGERY WAS DELAYED DUE TO THE REPORTED EVENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22299322 ↗
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- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
- DJO SURGICAL 342-10-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall51 reports
- DJO SURGICAL 341-10-707Encore Medical, L.P. · Guide, Surgical, Instrument81 reports
- NA 03.010.404Synthes GmbH · Guide, surgical, instrument73 reports
- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
- DJO SURGICAL 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.