NA 357.402Recalls & reported problems
Synthes GmbH · LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS · Class 1
Quick summary
This Synthes depth gauge is a measuring tool used with trochanteric fixation nails to size locking bolts during hip fracture surgery. The 36 reports mostly describe the gauge being found broken, often during audits of returned instruments rather than during surgery;2 injuries and no deaths are reported, and a few mention parts of the device breaking off. 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
- 36
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10886982196255), received between Dec 29, 2016 and Feb 23, 2022 — classified as 2 injuries, 34 malfunctions.
The most frequently reported specific device problem is “Break” (35 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.
Most reported problems
Device problems
- Break35
- Appropriate Device Problem Term/Code Not Available1
- Material Fragmentation1
Patient problems
- No Patient Involvement17
- No Consequences Or Impact To Patient10
- No Clinical Signs, Symptoms or Conditions7
- Device Embedded In Tissue or Plaque2
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 23, 2022Break; Break
IT WAS REPORTED THAT ON UNKNOWN DATE, ONE (1) PELVIC REDUCTION FORCEP, ONE (1) LISS INSERTION GUIDE FOR DISTAL FEMUR, ONE (1) DEPTH GAUGE FOR LOCKING SCREW, FOUR (4) UNIVERSAL CHUCK WITH T-HANDLE, ONE (1) CANNULATED 4.0MM HEXAGONAL SCREWDRIVER, ONE (1) PELVIC REDUCTION FORCEP, TWO (2) RIA DRIVE SHAFT, ONE (1) BENDING PLIERS, ONE (1) FORCEP FOR BROKEN SCREW REMOVAL, ONE (1) LOCKING PLIER, TWO (2) LARGE QUICK COUPLING, ONE (1) DEPTH GAUGE, ONE (1) SILICONE HANDLE, ONE (1) RED FORCEPS SERRATED JAW RATCHET, ONE (1) PLATE HOLDING FORCEP, ONE (1) REDUCTION FORCEP WITH POINT RATCHET, ONE (1) HOLDING SLEEVE WITH WING SCREW, ONE (1) GRAPHIC CASE AND TWO (2) GRAPHIC CASE FOR SCREW REMOVAL SET WERE BROKEN FROM USAGE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 3 OF 16 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13584472 ↗MalfunctionNov 12, 2021Break; Break
IT WAS REPORTED THAT, DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE THE LOCKING BOLT MEASURING DEVICE FOR TFN WAS FOUND BROKEN. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR (1) LCKNG BOLT MEASURING DEVICE F/TFN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12804188 ↗MalfunctionNov 12, 2021Break; Break
IT WAS REPORTED THAT, DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE THE LOCKING BOLT MEASURING DEVICE F/TFN WAS FOUND BROKEN . NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) LOCKING BOLT MEASURING DEVICE F/TFN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12803939 ↗MalfunctionNov 12, 2021Break; Break
IT WAS REPORTED THAT, DURING THE REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICE AT MILLSTONE THE LOCKING BOLT MEASURING DEVICE WAS FOUND BROKE. THIS REPORT IS FOR ONE (1) LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12803634 ↗MalfunctionJan 27, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT ON (B)(6) 2020, THE LOCKING BOLT MEASURING DEVICE FOR TROCHANTERIC FIXATION NAIL WAS FOUND OUT BROKEN DURING REVERSE LOGISTIC AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT INVOLVES ONE (1) LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11240342 ↗MalfunctionJan 26, 2021Break; Break
IT WAS REPORTED ON (B)(6) 2020, ONE (1) LOCKING BOLT MEASURING DEVICE WAS BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: LOCKG BLT MEURSNG DVCE F/TROCHANTERIC FIXATION NLS, (LOT #H299833 & QTY UNKNOWN) THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11229695 ↗MalfunctionJan 4, 2021Break; Break
IT WAS REPORTED THAT ON (B)(6) 2020, THE LOCKING BOLT MEASURING DEVICE FOR TROCHANTERIC FIXATION NAIL WAS FOUND TO BE BROKEN DURING REVERSE LOGISTIC AUDIT OF RETURNED DEVICE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE (1) LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11112440 ↗MalfunctionJun 17, 2020Break; Break
IT WAS REPORTED THAT ON (B)(6) 2020 THE LOCKING BOLT MEASURING DEVICE WAS FOUND TO BE BROKEN DURING A REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 10164871 ↗MalfunctionApr 17, 2020Break; Break
IT WAS REPORTED THAT ON MARCH 24, 2020 THE LOCKING BOLT MEASURING DEVICE FOR TROCHANTERIC FIXATION NAILS WAS FOUND TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9975005 ↗MalfunctionApr 16, 2020Break; Break
IT WAS REPORTED ON MARCH 24, 2020, A LOCKING BOLT MEASURING DEVICE WAS FOUND BROKEN DURING REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9969370 ↗MalfunctionApr 16, 2020Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE LOCKING BOLT MEASURING DEVICE FOR TROCHANTERIC FIXATION NAILS WAS BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9967473 ↗MalfunctionApr 16, 2020Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, A LOCKING BOLT MEASURING DEVICE WAS FOUND TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9967418 ↗MalfunctionApr 8, 2020Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, A LOCKING BOLT MEASURING DEVICE WAS FOUND BROKEN DURING REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE (1) LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9937576 ↗MalfunctionApr 6, 2020Break; Break
IT WAS REPORTED ON MARCH 11, 2020, THE LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS WAS BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) LOCKING BOLT MEASURING DEVICE FOR TROCHANTERIC FIXATION NAILS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9930459 ↗MalfunctionApr 6, 2020Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, A LOCKING BOLT MEASURING DEVICE WAS FOUND BROKEN DURING REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICE AT (B)(4). THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE (1) LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9930314 ↗MalfunctionApr 6, 2020Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TWO (2) LOCKING BOLT MEASURING DEVICE FOR TROCHANTERIC FIXATION NAILS WERE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE (1) LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9930313 ↗MalfunctionApr 6, 2020Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS WAS BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE (1) LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9930310 ↗MalfunctionJan 31, 2020Break; Break
IT WAS REPORTED ON JANUARY 8, 2020, TWO (2) DEPTH GAUGE FOR LOCKING SCREWS, ONE DOES NOT FUNCTION WITH LOT NUMBER 7869711 AND THE OTHER LOT NUMBER 5411870 WAS BROKEN, AND ALL THE THREE (3) LOCKING BOLT MEASURING DEVICES THAT WERE ALSO BROKEN DURING THE REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 9653419 ↗MalfunctionJan 30, 2020Break; Break
IT WAS REPORTED ON (B)(6) 2020, ONE (1) STEPPED DRILL BIT CANNULATED DID NOT FUNCTION; SIX (6) DEPTH GAUGE FOR LOCKING SCREWS, TWO (2) LOCKING BOLT MEASURING DEVICE, AND ONE (1) TITANIUM STERNAL LOCKING STRAIGHT PLATE WERE FOUND TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR (1) LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 10 OF 10 OF (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9647739 ↗MalfunctionJan 30, 2020Break; Break
IT WAS REPORTED ON (B)(6) 2020, ONE (1) STEPPED DRILL BIT CANNULATED DID NOT FUNCTION; SIX (6) DEPTH GAUGE FOR LOCKING SCREWS, TWO (2) LOCKING BOLT MEASURING DEVICE, AND ONE (1) TITANIUM STERNAL LOCKING STRAIGHT PLATE WERE FOUND TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR (1) LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 04 OF 10 OF (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9647720 ↗MalfunctionJan 29, 2020Break; Break
LIBERTAS: IT WAS REPORTED ON (B)(6) 2019, A LOCKING BOLT MEASURING DEVICE WAS BROKEN DURING REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9643953 ↗MalfunctionJan 29, 2020Break; Break
IT WAS REPORTED TWO (2) 1.6MM GUIDE WIRE 410MM DO NOT FUNCTION AND ONE (1) LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS WAS BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 3 OF 3 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9643929 ↗MalfunctionJan 29, 2020Break; Break
IT WAS REPORTED ON (B)(6) 2020, ONE (1) HELICAL BLADE INSERTER, SIX (6) LOCKING BOLT MEASURING DEVICE AND TWO (2) DEPTH GAUGE FOR LOCKING SCREW WERE BROKEN AND ONE (1) HELICAL BLADE INSERTER DOES NOT FUNCTION DURING REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS A REPORT FOR (1)LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 9 OF 09 (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9642662 ↗MalfunctionJan 29, 2020Break; Break
IT WAS REPORTED ON (B)(6) 2020, ONE (1) HELICAL BLADE INSERTER, SIX (6) LOCKING BOLT MEASURING DEVICE AND TWO (2) DEPTH GAUGE FOR LOCKING SCREW WERE BROKEN AND ONE (1) HELICAL BLADE INSERTER DOES NOT FUNCTION DURING REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS A REPORT FOR (1)LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 8 OF 09 (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9642658 ↗MalfunctionJan 29, 2020Break; Break
IT WAS REPORTED ON (B)(6) 2020, ONE (1) HELICAL BLADE INSERTER, SIX (6) LOCKING BOLT MEASURING DEVICE AND TWO (2) DEPTH GAUGE FOR LOCKING SCREW WERE BROKEN AND ONE (1) HELICAL BLADE INSERTER DOES NOT FUNCTION DURING REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS A REPORT FOR (1)LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 2 OF 09 (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9642643 ↗
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
- MULTILOC 03.019.017Synthes GmbH · GAUGE, DEPTH119 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
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.