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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

Nov 2023: 0 reportsDec 2023: 2 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

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 ↗

Other PROBE devices

All PROBE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.