GAMMA 1320-1010Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613154972173), received between Jun 4, 2018 and Jul 9, 2020 — classified as 4 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE C CLIP AT THE TIP OF THE GAMMA 3+ TARGETING ARM WHERE THE NAIL ATTACHES BECAME DISLODGED IN THE PATIENT'S WOUND. IT WAS FURTHER REPORTED THAT THE C CLIP WAS SEEN ON THE FINAL X-RAY. SURGEON HAD TO RETRIEVE THE C CLIP FROM THE PATIENT¿S WOUND. SURGICAL DELAY: LESS THAN 1 MINUTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10254110 ↗
• MalfunctionJan 21, 2020Crack; Failure to Align; Crack; Failure to Align

  REP REPORTED VIA VOICEMAIL THAT THE DISTAL TARGETER MISSED THE NAIL. FINE CRACKS WERE OBSERVED IN THE CARBON FIBER ALONG THE NECK OF THE TARGETER. THERE WAS A SURGICAL DELAY OF 15 TO 20 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9611780 ↗
• MalfunctionAug 7, 2018Break

  IT WAS REPORTED THAT IN REMOVING A GAMMA NAIL FROM PATIENT'S LEFT FEMUR, A METAL RING ON THE END OF THE TARGETER BROKE OFF AND FELL IN THE PATIENT. THE BREAKAGE WAS NOT NOTICED AND WAS NOT CAUGHT WITH INTRA-OPERATIVE X-RAYS. POST OPERATIVE X-RAYS REVEALED THE PRESENCE OF THE RING. THE PATIENT IS DUE TO HAVE A TOTAL KNEE IMPLANT IN THE FUTURE, SURGEON'S PLAN IS TO REMOVE THE RING AT THAT TIME. WHILE THE TARGETER IS AVAILABLE FOR RETURN, THE RING CURRENTLY REMAINS IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7756109 ↗
• MalfunctionJun 4, 2018Detachment Of Device Component

  PRIMARY PROCEDURE, RIGHT FEMUR. IT WAS REPORTED THAT A RING CAME OFF OF THE TARGETER WHERE IT ATTACHES TO THE NAIL WHILE INSIDE THE PATIENT. THE SURGEON WAS ABLE TO RETRIEVE THE RING WITH A REPORTED SURGICAL DELAY OF LESS THAN 2 MINUTES. REP WAS NOT PRESENT FOR THE PROCEDURE. THE REP HAS PROVIDED A PICTURE OF THE TARGETER AND THE RING. THE TARGETER IS AVAILABLE FOR RETURN (THE NAIL WAS IMPLANTED), BUT THE RING WAS LOST BY THE HOSPITAL. NO ADVERSE CONSEQUENCES TO PATIENT DUE TO SURGICAL DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7567242 ↗