NA 386.902Recalls & reported problems
Synthes GmbH · FRAGMENT MANIPULATOR/THREADED 1.9MM/SELF-DRILLING · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10887587040417), received between Mar 13, 2025 and Mar 13, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (5 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
- Material Twisted/Bent5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT SEVERAL INSTRUMENTS ARE OLD AND WORN. DEPTH GAUGE WAS BENT AND GIVING WRONG READINGS NO PATIENT WAS INVOLVED; NO SURGERY DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21595440 ↗MalfunctionMar 13, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT SEVERAL INSTRUMENTS ARE OLD AND WORN. DEPTH GAUGE WAS BENT AND GIVING WRONG READINGS NO PATIENT WAS INVOLVED; NO SURGERY DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21595437 ↗MalfunctionMar 13, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT SEVERAL INSTRUMENTS ARE OLD AND WORN. DEPTH GAUGE WAS BENT AND GIVING WRONG READINGS NO PATIENT WAS INVOLVED; NO SURGERY DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21595423 ↗MalfunctionMar 13, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT SEVERAL INSTRUMENTS ARE OLD AND WORN. DEPTH GAUGE WAS BENT AND GIVING WRONG READINGS, NO PATIENT WAS INVOLVED, NO SURGERY DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21595417 ↗MalfunctionMar 13, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT SEVERAL INSTRUMENTS ARE OLD AND WORN. DEPTH GAUGE WAS BENT AND GIVING WRONG READINGS NO PATIENT WAS INVOLVED; NO SURGERY DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21595416 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
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- 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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