NA 6007-003-100Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · NAVIGATION PIN 3 MM X 100 MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 37613154107392), received between Mar 6, 2020 and Dec 15, 2021 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Fracture2
- Biocompatibility1
- No Apparent Adverse Event1
Patient problems
- Bone Fracture(s)1
- Device Embedded In Tissue or Plaque1
- Fluid Discharge1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 15, 2021Biocompatibility; No Apparent Adverse Event; Biocompatibility; No Apparent Adverse Event
IT WAS REPORTED THAT FIVE DAYS AFTER A PROCEDURE AT THE USER FACILITY FLUID WAS PRESENT AT THE WOUND SITE WHERE NAVLOCK PINS WERE PLACED. THE PINS WERE NOTED TO HAVE BEEN PLACED IN THE REGION OF THE PATIENT'S TIBIA. THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.
Patient problems: Fluid Discharge
MAUDE report 13012380 ↗MalfunctionSep 21, 2021Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY A SURGICAL PIN SNAPPED WHILE DOING A KEEL PUNCH. THE DEVICE WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions
MAUDE report 12510109 ↗InjuryMar 6, 2020Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY A PATIENT EXPERIENCED A FRACTURE OF THE FEMUR AT THE DIAPHYSIS. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT; NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.
Patient problems: Bone Fracture(s)
MAUDE report 9800125 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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