LCP 03.113.028Recalls & reported problems
Synthes GmbH · DEPTH GAUGE F/3.5MM LCP PERCUTANEOUS INSTRUMENT SYSTEM · Class 1
- 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 10886982072948), received between Mar 28, 2024 and Jan 14, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Corroded1
- Material Deformation1
- Material Twisted/Bent1
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.
MalfunctionJan 14, 2026Break; Corroded; Material Twisted/Bent
IT WAS REPORTED THAT GRAPHICS CASES AND INSTRUMENTS ARE CHIPPING AND SHOWING SIGNS OF CORROSION OR WEAR AND BREAKING DOWN SO THE CSPD DEPARTMENT REFUSES TO REPROCESS THEM. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24066484 ↗MalfunctionMar 28, 2024Material Deformation; Material Deformation
IT WAS REPORTED ON (B)(6) 2024, DURING A PHILOS PROX HUMERUS WITH AIMING ARM, SLEEVE WAS DISENGAGING AND NOT CLICKING. TWO OF THEM WERE BROKEN ALONG WITH DEPTH GAUGE BENT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) DEPTH GAUGE F/3.5 LCP PERC INST SYS THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18996752 ↗
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.