NA SD388.750Recalls & reported problems
Synthes GmbH · TABLE TOP ROD CUTTER AND BENDER-TAPERED · Class 1
Data updated Oct 16, 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 10705034707181), received between Dec 23, 2024 and Dec 23, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem1
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.
MalfunctionDec 23, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6), 2024. DURING THE PROCEDURE, A ROD CUTTER BROKE WHILE THE SURGEON CUT THE BAR. ALL FRAGMENTS WERE REMOVED EASILY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21006558 ↗
Other CUTTER, SURGICAL devices
- NA 214646Medos International Sàrl · CUTTER, SURGICAL361 reports
- Sklar Instruments 96-2666ASklar Corporation · CUTTER, SURGICAL1 recall0 reports
- Sklar Instruments 96-2666Sklar Corporation · CUTTER, SURGICAL1 recall0 reports
- Sklar Instruments 96-2667Sklar Corporation · CUTTER, SURGICAL1 recall0 reports
- Sklar Instruments 96-2671ASklar Corporation · CUTTER, SURGICAL1 recall0 reports
- NA 214605Medos International Sàrl · CUTTER, SURGICAL17 reports
- NA 388.750Synthes GmbH · CUTTER, SURGICAL14 reports
- Aortic Cutter 3.8MM AC-3038Maquet Cardiovascular LLC · Cutter, Surgical12 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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