REDUCTION INSTRUMENT 38-709-03-07Recalls & reported problems
KLS-Martin L.P. · BYRD · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888118063274), received between Apr 4, 2018 and Dec 1, 2022 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (3 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 18, 2026.
Most reported problems
Device problems
- Break3
Patient problems
- Device Embedded In Tissue or Plaque2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 1, 2022Break; Break
IT WAS REPORTED THAT A BYRD REDUCTION TOOL BROKE DURING USE. A PORTION REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 15901031 ↗InjuryJul 9, 2020Break; Break
IT WAS REPORTED THAT BYRD REDUCTION INSTRUMENT BROKE AND A PORTION REMAINED IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10255090 ↗InjuryApr 4, 2018Break; Break
IT WAS REPORTED THAT AN INSTRUMENT BROKE DURING A FRACTURE REDUCTION. ALL REMAINING PIECES WERE SUCCESSFUL REMOVED WITHOUT FURTHER COMPLICATIONS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7395626 ↗
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- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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.
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