BLADE 38-709-06-07Recalls & reported problems
KLS-Martin L.P. · FOR ZYGOMA REDUCTION DEVICE, BYRD, DRILL FREE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888118114372), received between Nov 29, 2019 and Dec 5, 2025 — classified as 9 injuries.
The most frequently reported specific device problem is “Break” (8 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break8
- Fracture1
Patient problems
- Device Embedded In Tissue or Plaque9
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryDec 5, 2025Fracture; Fracture
IT WAS REPORTED DURING INITIAL SURGERY A BYRD BLADE FRACTURED DURING USE. A PORTION OF IT REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23728213 ↗InjuryFeb 20, 2025Break; Break
IT WAS REPORTED A BYRD BLADE BROKE DUE TO THE ANGLE AND TORQUE DURING USE. A PORTION REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21426413 ↗InjuryAug 21, 2024Break; Break
SURGICAL FELLOW BROKE TIP OF THREADED REDUCTION TOOL OFF DURING REDUCTION OF FRACTURE. A PORTION OF TIP REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 20016849 ↗InjurySep 28, 2023Break; Break
IT WAS REPORTED DURING INITIAL SURGERY A BYRD BLADE BROKE DURING USE. A PORTION OF IT REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 17831228 ↗InjuryNov 23, 2022Break; Break
IT WAS REPORTED A BYRD BLADE BROKE DURING USE. A PORTION REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 15852897 ↗InjuryNov 23, 2022Break; Break
IT WAS REPORTED THAT A BYRD BLADE BROKE DURING USE. A PORTION REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 15852881 ↗InjuryOct 6, 2022Break; Break
IT WAS REPORTED THE BYRD BLADE BROKE AND PORTION REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 15555918 ↗InjuryApr 25, 2022Break; Break
IT WAS REPORTED THAT A BLADE BROKE DURING USE. A PORTION REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 14197452 ↗InjuryNov 29, 2019Break; Break
IT WAS REPORTED THE INSTRUMENT BROKE DURING USE. A PORTION REMAINS IMPLANTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9391981 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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