MULTILOC 03.019.017Recalls & reported problems
Synthes GmbH · DEPTH GAUGE FOR MULTILOC HUMERAL NAILING SYSTEM · Class 1
Quick summary
This Synthes Multiloc depth gauge is a surgical measuring tool used when repairing upper arm bones with a nail. Many of the 114 reports describe the gauge breaking, its probe falling off, or its quick-connect failing to latch onto the screwdriver. No injuries or deaths are recorded, and reports often say there was no patient harm. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 119
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 119 adverse event reports that list this exact device (DI 10886982069559), received between Feb 8, 2017 and Sep 16, 2026 — classified as 119 malfunctions.
The most frequently reported specific device problem is “Break” (72 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break72
- Mechanical Jam20
- Material Deformation16
- Detachment of Device or Device Component8
- Device-Device Incompatibility5
- Incorrect Measurement4
- Entrapment of Device2
- Device Fell1
Patient problems
- No Clinical Signs, Symptoms or Conditions107
- Insufficient Information5
- No Patient Involvement4
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 119 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Device-Device Incompatibility; Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793424 ↗MalfunctionSep 16, 2026Device-Device Incompatibility; Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793423 ↗MalfunctionSep 9, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696660 ↗MalfunctionSep 8, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678098 ↗MalfunctionAug 25, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50436644 ↗MalfunctionMay 14, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT WHEN THEY WENT TO MEASURE WITH THE DEPTH GAUGE AND THE PROBE FELL OFF. QUICK CONNECT WAS ALSO UNABLE TO OPEN AND LATCH ONTO SCREWDRIVER. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25173830 ↗MalfunctionMay 6, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT AN ORIF SURGERY FOR PROXIMAL HUMERUS FRACTURE ON HUMERUS WITH THE PRODUCT IN QUESTION. IN THE SURGERY, A MULTILOC SHORT SCREW (8MM DIAMETER) WAS USED. THE OPERATION PROCEEDED SMOOTHLY UNTIL THE FIRST DISTAL LATERAL FIXATION STEP WAS COMPLETED, AT WHICH POINT THE INCIDENT OCCURRED. AFTER DRILLING, THE SURGEON MEASURED WITH THE DEPTH GAUGE IN QUESTION AND THEN REMOVED IT. THE THIN TIP OF THE DEPTH GAUGE SEPARATED FROM THE BASE OF THE MAIN BODY (THE PART WITH THE MARKINGS) AND REMAINED IN THE DRILLED HOLE. IT WAS REMOVED WITH A KOCHER SCREWDRIVER, AND THE SECOND DISTAL SCREW WAS MEASURED USING THE DRILL BIT. THE OPERATION WAS COMPLETED WITHOUT FURTHER ISSUES. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE DEPTH GAUGE WAS NOT HANDLED ROUGHLY, BUT IT SEEMED TO HAVE COME OFF WITHOUT ANY APPARENT SENSATION. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25095319 ↗MalfunctionApr 28, 2026Break
IT WAS REPORTED THAT (B)(6) 2026, THE PATIENT UNDERWENT ORIF SURGERY FOR FRACTURE OF THE HUMERAL SHAFT FOR HUMERAL SHAFT. BEFORE THE SURGERY, UPON CHECKING THE EQUIPMENT, IT WAS FOUND THAT THE PRODUCT IN QUESTION WAS DAMAGED. THE PRODUCT IN QUESTION WAS NOT STERILIZED, AND ANOTHER INSTRUMENT WAS USED AS A SUBSTITUTE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25016884 ↗MalfunctionApr 27, 2026Mechanical Jam
IT WAS REPORTED THAT THE DEVICE DOESN'T SLIDE AS INTENDED. THERE WAS NO REPORTED PATIENT OR USER HARM, AND NO SIGNIFICANT DELAY WAS NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25000464 ↗MalfunctionApr 27, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING USE, THE PROBE OF THE DEPTH GAUGE FELL OFF AND THE QUICK CONNECT WAS UNABLE TO OPEN AND LATCH ONTO THE SCREWDRIVER. THERE WAS NO REPORTED PATIENT HARM OR SIGNIFICANT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24998490 ↗MalfunctionApr 22, 2026Break
IT WAS REPORTED THE DEPTH GAUGE HAD A BROKEN INLAY. THE EVENT WAS DISCOVERED POST-OPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24957212 ↗MalfunctionMar 9, 2026Material Deformation
ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THERE WAS NO OPERATION INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24547385 ↗MalfunctionMar 5, 2026Break
IT WAS REPORTED THAT THE SPD NOTICED THE DEPTH GAUGE WAS MISSING THE TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24519928 ↗MalfunctionMar 4, 2026Break
IT WAS REPORTED ON AN UNKNOWN DATE, THAT THE PRONGED EXTENSION ON THE DEPTH GAUGE SNAPPED IN HALF DURING A CLEANING CYCLE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24506717 ↗MalfunctionMar 3, 2026Mechanical Jam
IT WAS REPORTED THAT THE BOTH PART OF DEPTH GAUGE ARE STUCK TOGETHER, WITH THE INNER PART DESCRIBED AS TOO SOFT COMPARED TO THE OUTER PART AND APPEARING TO OVERBEND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24500024 ↗MalfunctionFeb 27, 2026Material Deformation
IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING, IT WAS IDENTIFIED THAT THE FINE METAL TIPS OF THE TWO (2) DEPTH HOOKS HAD BECOME DEFORMED AND BENT AND WERE DEEMED TO BE NO LONGER FUNCTIONAL. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24475057 ↗MalfunctionFeb 27, 2026Material Deformation
IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING, IT WAS IDENTIFIED THAT THE FINE METAL TIPS OF THE TWO (2) DEPTH HOOKS HAD BECOME DEFORMED AND BENT AND WERE DEEMED TO BE NO LONGER FUNCTIONAL. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24475053 ↗MalfunctionFeb 26, 2026Detachment of Device or Device Component
DURING AN ORTHOPEDIC PROCEDURE, A DEPTH GAUGE RELATING TO THE ANS NAILING SYSTEM CAME LOOSE. THE EQUIPMENT WAS NOT DAMAGED OR BENT, AND THE ORTHOPEDIC SURGEON EXPLAINED THAT IT HAD SIMPLY DETACHED DURING THE PROCEDURE. THIS PROBLEM DID NOT AFFECT THE PROCEDURE OR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24456281 ↗MalfunctionFeb 23, 2026Mechanical Jam
IT WAS REPORTED THAT A DEPTH GAUGE AND COMPONENT ARE STUCK TOGETHER. BOTH PARTS OF THE DEPTH GAUGE CANNOT SLIDE TOGETHER ANYMORE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24413992 ↗MalfunctionFeb 18, 2026Break
IT WAS REPORTED THAT DURING PREP/HANDLING THE END OF THE DEPTH GAUGES BROKE OFF. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24379940 ↗MalfunctionFeb 18, 2026Break
IT WAS REPORTED THAT DURING PREP/HANDLING THE END OF THE DEPTH GAUGES BROKE OFF. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24379939 ↗MalfunctionFeb 10, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE INNER PART OF THE DEPTH GAUGE IS DENTED AND DOES NOT SLIDE PROPERLY ANYMORE. THERE WAS A TWO (2) MINUTE SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24304519 ↗MalfunctionFeb 6, 2026Incorrect Measurement; Mechanical Jam
IT WAS REPORTED THAT THE OUTER SLEEVE IS HARD TO SLIDE OVER THE INNER SLEEVE OF THE DEPTH GAUGE. IT MAKES IT HARD TO USE TO DETERMINE THE SCREW LENGTH THAT IS NEEDED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24277838 ↗MalfunctionJan 27, 2026Mechanical Jam
IT WAS REPORTED THAT THE DEVICE DOES NOT SLIDE WELL. NO OPERATION INVOLVED. NO PATIENT CONSEQUENCES. NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24188652 ↗MalfunctionJan 23, 2026Break
IT WAS REPORTED THAT THE PIECE DID NOT FAIL DURING THE PROCEDURE AND THERE WAS NO PATIENT OR SURGEON INVOLVEMENT. THE THIN PIECE OF THE DEPTH GAUGE WAS BROKEN OFF OF THE THICKER PIECE WHEN THE PIECE CAME OUT OF THE WASH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24159884 ↗
Other GAUGE, DEPTH devices
- NA 319.006Synthes GmbH · GAUGE, DEPTH899 reports
- NA 03.133.080Synthes GmbH · GAUGE, DEPTH174 reports
- NA 03.010.072Synthes GmbH · GAUGE, DEPTH133 reports
- NA 319.01Synthes GmbH · GAUGE, DEPTH113 reports
- NA 319.004Synthes GmbH · GAUGE, DEPTH82 reports
- QUICKSET 2274-60-000Depuy (Ireland) · GAUGE, DEPTH68 reports
- NA 319.09Synthes GmbH · GAUGE, DEPTH65 reports
- NA 319.091Synthes GmbH · GAUGE, DEPTH64 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.