GAMMA 1320-3010Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540396860), received between Sep 23, 2015 and Jun 8, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2022Positioning Failure; Positioning Failure

  AS REPORTED: "DURING THE GAMMA 3 SURGERY, WHEN THE ONE-SHOT GUIDE WAS USED, THE IMAGE WAS CLEARLY MISALIGNED AND COULD NOT BE ACCURATELY TARGETED. WHEN OTHER INSTRUMENT WAS USED AS A SUBSTITUTE, IT FUNCTIONED AS NORMAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14630778 ↗
• InjuryJul 20, 2020Fracture; Fracture

  THE CUSTOMER REPORTED THAT : "DURING THE INSTALLATION OF A NAIL GAMMA3 BY [SURGEON], A RUPTURED INSTRUMENT SET OCCURRED DURING THE LOCKING OF THE CEPHALIC SCREW; RESULTING IN THE LOSS OF A PART OF THE DEVICE, WHICH CAME IN THE SOFT PARTS OF THE PATIENT'S HIP." THE CUSTOMER REPLIED: "THE EVENT OCCURRED DURING THE INTERVENTION, WHEN THE SCREW WAS LOCKED. THE PROCEDURE MAY HAVE BEEN COMPLETED, BUT ADDITIONAL MANIPULATION WAS REQUIRED WHEN THE UNSUCCESSFUL ATTEMPT WAS MADE TO RETRIEVE THE PIECE OF THE DEVICE THAT WAS LOST FROM THE PATIENT. THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT AT THIS TIME."

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 10299946 ↗
• MalfunctionOct 21, 2019Failure to Align

  IT WAS REPORTED THAT THE INSERTION POSITION INDICATED BY THE ONE SHOT GUIDE AND THE POSITION OF THE ACTUALLY INSERTED GUIDE PIN WERE MISALIGNED DURING GAMMA3 OPERATION. THEREFORE, THE ONE SHOT GUIDE WAS NOT USED AND THE OPERATION WAS CONTINUED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9216232 ↗
• MalfunctionAug 22, 2019Failure to Align; Material Deformation; Material Deformation

  IT WAS REPORTED THAT WHEN THE ONE SHOT DEVICE WAS USED IT WAS NOTICED THAT THE LINES ONE X-RAY INDICATING LAG SCREW POSITION DID NOT ALIGN WITH THE HOLE IN THE NAIL. LOOKING ALONG THE LENGTH OF THE ONE SHOT DEVICE IT WAS NOTED THAT THERE WAS A TWIST ALONG ITS LENGTH. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY OR ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8922764 ↗
• MalfunctionNov 5, 2018Material Deformation

  THE ONE SHOT TARGET DEVICE IS BENT, CAUSING AN INACCURATE DRILLING FOR FEMORAL NECK SCREWS. THERE IS A PLASTIC DEFORMATION OF THE DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8039731 ↗
• MalfunctionSep 23, 2015Malposition of Device

  DURING NAIL SURGERY, WHEN THE SURGEON USED THE ONE SHOT GUIDE, THE INDICATOR (WIRE) WASN'T SEEN AT THE NORMAL LOCATION. THEREFORE THE SURGEON DID NOT USE THE ONE SHOT GUIDE AND THE SURGERY WAS COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5096896 ↗