GAMMA 1320-5320Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613154985760), received between Jan 6, 2020 and May 25, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 25, 2021Failure to Align; Adverse Event Without Identified Device or Use Problem; Failure to Align; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "THE ADAPT SYSTEM INITIALLY DID NOT RECOGNIZE THE SLEEVE FOR THE SHS AND THE DISTAL LOCKING WAS DRILLED PAST. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT THE ADAPT SYSTEM. A LONG G3 NAIL WAS IMPLANTED / MEANS PROXIMAL + DISTAL TARGET DEVICE WAS IN USE. ADAPT WAS CONNECTED THE WHOLE SURGERY BUT IGNORED WHEN THE EXPECTED INFORMATION WAS NOT PROVIDED. THE NAIL WAS LOCKED MANUALLY AT DISTAL WITH 2 SCREWS. DELAY IN SURGERY WAS 1H." ADDITIONAL INFORMATION RECEIVED FROM THE SURGEON: THE ADAPT SYSTEM DID NOT INITIALLY RECOGNIZE THE SLEEVE FOR THE SHS AND THE DISTAL LOCK WAS DRILLED PAST. THE ADAPT DID NOT RECOGNIZE THE K-WIRE ON THE SHS AT TIMES EVEN THOUGH THERE WERE ENOUGH POINTS IN THE BEAM PATH. FURTHERMORE, IT DIRECTED ME TOO FAR VENTRALLY IN 2ND PLANE. AFTER ANOTHER X-RAY IN THE AP-PLANE, IT KEPT ASKING ME TO X-RAY OTHER PLANES, ALTHOUGH THE CALCULATION HAD ALREADY BEEN DONE. IN THE MEANTIME, IT HAD ALREADY CALCULATED A TAD ON THE DRILL. THEN IT DID NOT RECOGNIZE THE SHS. THE SURGERY PROXIMAL SIDE WAS COMPLETED USING THE ADAPT, EVEN THOUGH SOME OF THE RECOMMENDATIONS HAD TO BE IGNORED AS THE SYSTEM DID NOT SHOW CORRECT VALUES. THE ADAPT SYSTEM WAS CONNECTED UNTIL THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11881356 ↗
• MalfunctionJan 6, 2020Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  OUR AGENT, DURING A WORKSHOP, FOUND THAT ONE DEVICE: AFTER HAVING MOUNTED THE DTS ARM ON THE CARBON HANDLE OF THE GAMMA COD. 1320-0111 ON WHICH A RIGHT GAMMA 3 LONG NAIL WAS MOUNTED, IT WAS ABSOLUTELY NOT POSSIBLE TO INSERT THE PIN COD. 1320-5330 WHICH REMAINED COMPLETELY OUT OF THE HOLE. SIMULATING INSTEAD THE USE OF A LEFT NAIL, THE PIN COD. 1320-5330 ENTERED IN PART, RESULTING HOWEVER DECENTRALIZED WITH RESPECT TO THE EXIT HOLE. THE OTHER DEVICE (SAME LOT): MOUNTING THE ARM ON THE GAMMA3 CARBON DEVICE AND INSERTING THE LOCKING PIN, THE PIN ITSELF DID NOT ENGAGE, BEING OFF-CENTER WITH RESPECT TO THE EXIT HOLE. THE PROBLEM OCCURS ONLY ON THE LONG DX NAIL, NOT ON THE LEFT. HE TRIED WITH ANOTHER DEVICE (DIFFERENT LOT) WHIT NO ISSUE. NO PATIENT INVOLVEMENT, NO ASSOCIATED PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 9555521 ↗
• MalfunctionJan 6, 2020Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  OUR AGENT, DURING A WORKSHOP, FOUND THAT ONE DEVICE: AFTER HAVING MOUNTED THE DTS ARM ON THE CARBON HANDLE OF THE GAMMA COD. 1320-0111 ON WHICH A RIGHT GAMMA 3 LONG NAIL WAS MOUNTED, IT WAS ABSOLUTELY NOT POSSIBLE TO INSERT THE PIN COD. 1320-5330 WHICH REMAINED COMPLETELY OUT OF THE HOLE. SIMULATING INSTEAD THE USE OF A LEFT NAIL, THE PIN COD. 1320-5330 ENTERED IN PART, RESULTING HOWEVER DECENTRALIZED WITH RESPECT TO THE EXIT HOLE. THE OTHER DEVICE (SAME LOT): MOUNTING THE ARM ON THE GAMMA3 CARBON DEVICE AND INSERTING THE LOCKING PIN, THE PIN ITSELF DID NOT ENGAGE, BEING OFF-CENTER WITH RESPECT TO THE EXIT HOLE. THE PROBLEM OCCURS ONLY ON THE LONG DX NAIL, NOT ON THE LEFT. HE TRIED WITH ANOTHER DEVICE (DIFFERENT LOT) WHIT NO ISSUE. NO PATIENT INVOLVEMENT, NO ASSOCIATED PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 9555453 ↗