NA 03.501.065Recalls & reported problems
Synthes GmbH · CALIPER · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587010762), received between Oct 29, 2025 and Apr 27, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (2 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.
Reports received per month
Most reported problems
Device problems
- Incorrect Measurement2
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 27, 2026Incorrect Measurement
IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN USING THE CALIBRATOR THE CALIBRATOR DID NOT WORK PROPERLY AND IT WAS SOMEWHAT DIFFICULT FOR THE DOCTOR TO PERFORM THE MEASUREMENT. EVEN SO, WITH THE SAME CALIBRATOR IT WAS POSSIBLE TO COMPLETE THE SURGERY SUCCESSFULLY, WITHOUT DISCOMFORT FOR THE SPECIALIST, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25002490 ↗MalfunctionOct 29, 2025Incorrect Measurement; Material Deformation; Incorrect Measurement; Material Deformation
IT WAS REPORTED ON AN UNKNOWN DATE THAT THE CALIPER WILL NOT MOVE PROPERLY TO MEASURE & THE METAL WAS BENT SO MEASUREMENT WAS INACCURATE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23413437 ↗
Other TAPE, MEASURING, RULERS AND CALIPERS devices
- TRIGEN 71674079Smith & Nephew, Inc. · TAPE, MEASURING, RULERS AND CALIPERS454 reports
- P.F.C. 86-9188Depuy (Ireland) · TAPE, MEASURING, RULERS AND CALIPERS19 reports
- TRIGEN 71631128Smith & Nephew, Inc. · TAPE, MEASURING, RULERS AND CALIPERS4 reports
- TRIGEN MAX 72502005Smith & Nephew, Inc. · TAPE, MEASURING, RULERS AND CALIPERS1 report
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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