MULTILOC 03.019.029Recalls & reported problems
Synthes GmbH · DEPTH PROBE FOR MULTILOC HUMERAL NAILING SYSTEM · Class 1
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886982069696), received between Jan 13, 2016 and Aug 5, 2025 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Break” (12 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
- Break12
- Component Missing1
- Device-Device Incompatibility1
- Illegible Information1
- Incorrect Measurement1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Patient Involvement4
- No Consequences Or Impact To Patient2
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2025Break; Break
IT WAS REPORTED THAT ON JULY 01, 2025, UPON EXAMINATION AFTER DECONTAMINATION IT WAS DETERMINED THAT THE INSTRUMENT WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22718592 ↗MalfunctionOct 21, 2024Break; Break
IT WAS REPORTED THAT THE DEPTH GAUGE BROKE IN THE CASE. THE MEASURING PART BROKE OFF FROM MAIN PART. SURGERY WAS COMPLETED WITH DIFFICULTY. NO FURTHER DETAILS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20492944 ↗MalfunctionSep 9, 2024Break; Break
THE TIMING OF THE REPORTED EVENT WAS DURING POST-OP, AND THE SURGERY WAS SUCCESSFULLY COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20170032 ↗MalfunctionApr 17, 2024Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEPTH GAUGES BROKE IN THE WASH. THE EVENT OCCURRED DURING STERILE PROCESSING AND FIELD INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE DEPTH PROBE FOR MULTILOC HUMERAL NAILING SYSTEM. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19124492 ↗MalfunctionDec 6, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NETHERLANDS AS FOLLOWS: IT WAS REPORTED THAT THE LOANER SET CONTAINS DEFECTIVE INSTRUMENT. ARTICLE NUMBER 03.019.029 WITH LOT NUMBER 86P0563. ITEM CANNOT BE ASSEMBLED. NO CONSEQUENCE OR DELAY. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) LENGTH PROBE F/MULTILOC HUM NAIL SYST. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18273132 ↗MalfunctionDec 1, 2023Incorrect Measurement; Illegible Information; Incorrect Measurement; Illegible Information
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. DURING SURGERY, THE SCALE ON THE TIP OF THE DEPTH GAUGE WAS UNREADABLE. THE SCALE FOR SCREW-IN-SCREW MEASUREMENT WAS ALMOST LOST, AND THE EXACT VALUE COULD NOT BE READ. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE PATIENT WAS REPORTED AS STABLE. THIS REPORT INVOLVES ONE (1) DEPTH PROBE FOR MULTILOC HUMERAL NAILING SYSTEM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18246082 ↗MalfunctionMar 31, 2023Break; Break
IT WAS REPORTED THAT THE REPRESENTATIVE WAS PUTTING THE SET BACK TOGETHER AND THE SAW BROKE. IT WAS UNKNOWN IF ANY FRAGMENTS WERE GENERATED AND NO PATIENT HARM REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) DEPTH PROBE FOR MULTILOC HUM NLING SYS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16657932 ↗MalfunctionJun 22, 2022Break; Break
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED BY THE SALES REP IN CANADA THAT DURING A ROUTINE TRAUMA CASE ON (B)(6) 2022, IT WAS OBSERVED THAT THE DEPTH PROBE DEVICE BROKE INTO TWO PIECES. ACCORDING TO THE REPORT, THE SURGEON WAS ABLE TO READ HIS MEASUREMENTS FROM THE CALIBRATED DRILL; AND THEREFORE, THE SURGERY WAS NOT DELAYED AND PROCEEDED AS PLANNED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14771414 ↗MalfunctionSep 29, 2020Component Missing; Component Missing
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE DEPTH PROBE FOR MULTILOC HUMERAL NAILING SYSTEM WAS MISSING A PIECE. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH PROBE FOR MULTILOC HUMERAL NAILING SYSTEM THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 10601282 ↗MalfunctionFeb 14, 2020Break; Break
IT WAS REPORTED THAT DURING RESTOCKING AND INSPECTION OF THE INSTRUMENT SET AT THE METRO OFFICE ON (B)(6) 2020, THE TIP OF THE DEPTH PROBE FOR HUMERAL NAILING SYSTEM WAS DISCOVERED BROKEN OFF. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9714420 ↗MalfunctionNov 13, 2019Break; Break
IT WAS REPORTED THAT ON (B)(6) 2019, THE HOOKED END OF A DEPTH PROBE FOR MULTILOC HUMERAL NAILING SYSTEM WAS MISSING DURING PRE-OP PRIOR TO AN UNKNOWN ORTHOPEDIC PROCEDURE. THIS REPORT IS FOR ONE (1) DEPTH PROBE FOR MULTILOC HUMERAL NAILING SYSTEM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9316831 ↗MalfunctionOct 25, 2019Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR HUMERAL NECK FRACTURE WITH THE DEPTH PROBE IN QUESTION. AFTER MEASURING WITH THE DEPTH PROBE, THE DEPTH PROBE FELL APART AT ITS NEEDLE NECK. THE SURGEON REMOVED THE FRAGMENT, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9240570 ↗MalfunctionJan 24, 2019Break; Break
IT WAS REPORTED THAT ON (B)(6) 2018, THE DEPTH PROBE FOR MULTILOC HUMERAL NAILING SYSTEM WAS USED IN AN UNKNOWN CASE AND WAS SENT TO THE WASH. WHEN THE SET WAS OPENED, IT WAS FOUND OUT THAT DEVICE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH PROBE FOR MULTILOC HUMERAL NAILING SYSTEM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Patient Involvement
MAUDE report 8274875 ↗MalfunctionMar 23, 2017Break; Break
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE REPORTED DEVICE WAS SUPPOSED TO BE USED IN SURGERY FOR HUMERUS DIAPHYSIS FRACTURE ON (B)(6) 2017. HOWEVER, THE TIP OF A DEPTH PROBE WAS BROKEN WHEN THE SURGEON CHECKED IT BEFORE SURGERY. THERE WAS NO PATIENT HARM; NO OTHER MEDICAL INTERVENTION WAS REQUIRED. NO INFORMATION IS AVAILABLE ABOUT SURGICAL PROLONGATION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6428592 ↗MalfunctionJan 13, 2016Break; Break
SYNTHES (B)(4) REPORTED EVENTS IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE TIP OF THE DEPTH GAUGE WAS FOUND TO BE BROKEN DURING INSTRUMENT INSPECTION ON (B)(6) 2015. THIS INSTRUMENT IS PART OF A SYNTHES MULTILOC HUMERAL NAILING SYSTEM LOAN SET AND THE DEPTH GAUGE WAS DISCOVERED TO BE BROKEN BEFORE IT WAS DELIVERED TO THE HOSPITAL. THERE WAS NO REPORT OF PRIOR PATIENT OR SURGICAL INVOLVEMENT. IT IS UNKNOWN WHEN THE DEPTH GAUGE WAS BROKEN. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 5364940 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.