GAMMA 1320-0090Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04546540377661), received between Jun 13, 2019 and Dec 18, 2025 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (10 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Mechanical Jam; Mechanical Jam

  AS REPORTED: "THE TARGET DEVICE CANNOT BE DETACHED FROM THE IMPLANT. THE NAIL WAS COMPLETELY IMPLANTED, INCLUDING PROXIMAL AND DISTAL LOCKING. THE TARGET BAR COULD NO LONGER BE DISCONNECTED VIA THE NAIL RETAINING SCREW, SO AN ATTEMPT WAS MADE TO REMOVE THE DISTAL LOCKING. HOWEVER, THE TARGET BAR WAS IN THE WAY, SO AN ATTEMPT WAS MADE TO SHORTEN IT USING A SAW. ULTIMATELY, THE BAR AND NAIL WERE REMOVED USING A HAMMER. REPLACEMENT WAS AVAILABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839377 ↗
• MalfunctionMay 8, 2025Mechanical Jam; Mechanical Jam

  AS REPORTED: "IMPOSSIBLE TO REMOVE THE NAIL-HOLDER BOLT AND THEREFORE THE NAIL-HOLDER FROM THE NAIL. OBLIGED TO REMOVE THE NAIL MOUNTED ON THE NAIL HOLDER AND REPEAT THE OP WITH ANOTHER GAMMA3 ANCILLARY. CHANGE ANCILLARY AND IMPLANT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21985729 ↗
• MalfunctionJul 9, 2024Break; Fracture; Material Deformation; Break; Fracture; Material Deformation

  NAIL HOLDING SCREW DID NOT LOOSEN WITH NORMAL FORCE. EVENTUALLY, THE DEVICE WAS REMOVED, BUT DAMAGE OF THE NAIL HOLDING SCREW AND STRIKE PLATE WAS OBSERVED. THERE PATIENT HAD NO IMPACT AND SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19705106 ↗
• InjuryMar 6, 2024Problem with Sterilization; Problem with Sterilization

  AS REPORTED: "DURING A GAMMA 3 SURGERY, IT WAS DISCOVERED THAT TWO NAIL HOLDING SCREWS HAD NOT BEEN STERILIZED JUST PRIOR TO THE SURGERY. THE PATIENT WAS ALREADY UNDER LUMBAR ANESTHESIA, BUT HOSPITAL RULES REQUIRED THAT THE SURGERY BE POSTPONED TO TUESDAY BECAUSE OF THE THREE-HOUR STERILIZATION PROCESS. DAMAGE FROM UNNECESSARY ANESTHESIA, POSTPONEMENT OF SURGERY."

  Patient problems: Insufficient Information

  MAUDE report 18850640 ↗
• InjuryMar 6, 2024Problem with Sterilization; Problem with Sterilization

  AS REPORTED: "DURING A GAMMA 3 SURGERY, IT WAS DISCOVERED THAT TWO NAIL HOLDING SCREWS HAD NOT BEEN STERILIZED JUST PRIOR TO THE SURGERY. THE PATIENT WAS ALREADY UNDER LUMBAR ANESTHESIA, BUT HOSPITAL RULES REQUIRED THAT THE SURGERY BE POSTPONED TO TUESDAY BECAUSE OF THE THREE-HOUR STERILIZATION PROCESS. DAMAGE FROM UNNECESSARY ANESTHESIA, POSTPONEMENT OF SURGERY."

  Patient problems: Insufficient Information

  MAUDE report 18850021 ↗
• MalfunctionJan 30, 2024Mechanical Jam; Mechanical Jam

  AS REPORTED: "THE NAIL GETS STUCK IN THE TARGET DEVICE GAMMA3. THE PROCEDURE WAS COMPLETED WITH ANOTHER INSTRUMENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610688 ↗
• MalfunctionFeb 1, 2023Mechanical Jam; Mechanical Jam

  AS REPORTED: "THE END USER REPORTED THAT GAMMA3 NAIL CAN NO LONGER BE DISCONNECTED FROM THE NAIL HOLDING SCREW AND THE AIMING DEVICE." COMPLETELY HAD TO BE REMOVED, NEW IMPLANT HAD TO BE PLACED FREEHAND AND THE PROCEDURE TOOK LONGER, LEADING TO AN UNKNOWN SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16280458 ↗
• MalfunctionMay 24, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED: "THE SURGERY WAS ALMOST COMPLETE WHEN THE AIMING DEVICE WAS TO BE REMOVED, IT WAS NOT DETACHABLE. THE AIMING DEVICE CANNOT BE REMOVED FROM THE LONG GAMMA NAIL. THERE WAS A QUASI COLD CONNECTION BETWEEN THE IMPLANT AND THE INSERTION AID. CONSEQUENCE: REMOVAL OF THE ALREADY FULLY IMPLANTED NAIL INCL. FEMORAL NECK SCREW AND DISTAL LOCKING AND RE-IMPLANTATION OF A NEW NAIL. THE PROCEDURE WAS DELAYED BY 1H WHICH LEAD TO HIGHER BLOOD LOSS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14487199 ↗
• MalfunctionMay 23, 2022Mechanical Jam; Mechanical Jam

  AS REPORTED: "WE HEREBY INFORM YOU THAT YESTERDAY (B)(6) 2022, AT 7.45 PM, AT THE (B)(6) CLINIC, A GAMMA NAIL SURGERY TOOK PLACE. THE PROCEDURE WAS CARRIED OUT CORRECTLY FROM THE EARLY STAGES OF ASSEMBLY UP TO THE IMPLANTATION OF THE DISTAL SCREW. EVERYTHING AS USUAL. WHEN IT WAS TIME TO UNSCREW THE SCREW THAT LOCKS THE NAIL TO THE CARBON MASK, HOWEVER, IT SHOWED NO SIGNS OF YIELDING EVEN BY A MILLIMETER. CONSEQUENTLY, THE OPERATOR HAD TO REMOVE THE NAIL FROM THE PATIENT, HOPING THAT ON THE OPERATING TABLE IT WOULD BE EASIER TO REMOVE IT FROM THE MASK. NOT EVEN WITH THE USE OF A VICE WERE THEY ABLE TO MOVE THE SCREW. AT THAT POINT THE AGENT, IN URGENCY AND TO COMPLETE THE INTERVENTION, WAS FORCED TO TAKE A GAMMA 3 INSTRUMENTATION IN STORAGE AT THE AURELIA HOSPITAL TO TAKE IT TO PAIDEIA, WHERE IT WAS STERILIZED AND THEN, WITH ABOUT TWO HOURS OF DELAY FROM THE PRACTICE, THE OPERATOR HAS FINALLY FINISHED THE NAIL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14473871 ↗
• MalfunctionMar 12, 2022Mechanical Jam; Mechanical Jam

  AS REPORTED; "THE TARGET DEVICE AND THE HOLDING SCREW WERE STUCK AND COULD NOT BE REMOVED FROM THE NAIL AFTER THE NAIL INSERTION. AFTER THAT, OTHER INSTRUMENTS AND NAIL WERE USED AND THE SURGERY WAS FINISHED." TIME EXTENSION OF ABOUT 20 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13743572 ↗
• MalfunctionJan 28, 2022Mechanical Jam; Mechanical Jam

  AS REPORTED: "SURGEON IMPACTED NAIL WITH SLEEVE ASSEMBLY INSTEAD OF THE STRIKE PLATE. DURING INSERTION OF THE K-WIRE, THE K-WIRE HIT THE NAIL AND THE K-WIRE COULD NOT BE REMOVED FROM THE SLEEVE. AT THE END OF THE CASE, IT WAS NOTICED THAT THE NAIL HOLDING BOLT WAS STUCK IN THE TARGETING ARM. THE IMPACTION WAS DONE WITH THE SLEEVES ON THE NAIL HOLDING BOLT. ANOTHER SET WAS OPENED AND REPLACEMENT PARTS USED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13388699 ↗
• MalfunctionDec 1, 2021Mechanical Jam; Mechanical Jam

  THE CUSTOMER REPORTED THAT THE GAMMA AIMING ARM COULD NO LONGER BE DETACHED FROM THE NAIL. WAS IT SOME KIND OF COLD WELDING? THE PROCEDURE COULD BE COMPLETED SUCCESSFULLY WITH A DELAY OF 20 MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12913346 ↗
• MalfunctionJul 14, 2021Separation Failure; Separation Failure

  CUSTOMER REPORTS A GAMMA3 TARGETING DEVICE THAT CAN'T BE DETACHED FROM THE GAMMA3 NAIL. THE NAIL WAS PROPERLY CONNECTED TO THE TARGETING DEVICE FOR IMPLANTATION OF A GAMMA NAIL (180 LENGTH). AT THE END OF THE SURGERY, THE RETAINING SCREW COULD NOT BE LOOSENED. AS A RESULT, IT WAS NECESSARY TO REMOVE THE ENTIRE GAMMA NAIL AND RE-IMPLANT A NEW GAMMA NAIL WITH A REPLACEMENT INSTRUMENT SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12166749 ↗
• MalfunctionMay 27, 2021Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED: "THE DOCTOR WAS PERFORMING AN INTRAMEDULLARY GAMMA NAIL ON THE PATIENT'S RIGHT SIDE. DURING THE IMPACTION OF THE NAIL THE LOCKING BOLT BEACON COLD WELDED TO THE NAIL AND WAS UNABLE TO SEPARATE THE TARGETED FROM THE NAIL. A NEW TARGETER TRAY WAS OPENED WITH ANOTHER LOCKING BOLT AS WELL AS A NEW NAIL. THE PROCEDURE WAS COMPLETE WITHOUT FURTHER INCIDENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11899082 ↗
• InjuryOct 29, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  AS REPORTED: "GAMMA NAILL GOT STUCK WITH THE NAIL RETAINING SCREW AND COULD NO LONGER BE REMOVED. CARETAKER CLAMPED A NAIL IN A VICE AND WAS ABLE TO LOOSEN THE CONNECTION. REPLACEMENT WAS AVAILABLE (31251200S LOT K0237EC) AND PROCEDURE WAS COMPLETED MANUALLY. SURGICAL DELAY OF 2 HOURS NOT LONGER. PATIENT HAD TO GET FOREIGN BLOOD DUE TO THE DURATION OF THE SURGERY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10757217 ↗
• MalfunctionOct 26, 2020Difficult to Remove; Difficult to Remove

  REP REPORTED THAT THE NAIL HOLDING SCREW WAS DIFFICULT TO REMOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10735161 ↗
• MalfunctionAug 18, 2020Fracture; Fracture

  CUSTOMER REPORTED THAT : "THE GAMMA NAIL BROKE WHEN IT WAS INSERTED INTO THE PATIENT. THE NAIL LOCKING NUT OR SCREW ON THE NAIL HOLDER BROKE IN THE NAIL. THE DEVICE COULD BE REMOVED AND REPLACED WITH A NEW ONE WITH A NEW INSERTION AID." ADDITIONALLY REPORTED: - THIS OCCURRED DURING PRIMARY IMPLANTATION. - NO DEBRIS REPORTED. - IT WAS THE "NAIL RETAINING SCREW" THAT BROKE OFF. - "NO MORE THAN A FEW MINUTES" OF DELAY.

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

  MAUDE report 10423159 ↗
• MalfunctionJun 8, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  DURING THE DRILLING FOR THE SHS, THE DRILL BIT RAN ONTO THE NAIL. THE ADJUSTMENTS ON THE INSERTION HANDLE WERE REPORTEDLY CORRECT AND THE K-WIRE WAS REPORTEDLY CORRECTLY POSITIONED SUBCHONDRALLY. THE NAIL HOLDING SCREW WAS THEN DIFFICULT TO REMOVE FROM THE NAIL. REPLACEMENT WAS AVAILABLE. SURGICAL DELAY OF 10MIN. NOT LONGER.

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

  MAUDE report 10130660 ↗
• MalfunctionMay 7, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  CUSTOMER REPORTED TO SALES REP THAT: "WE HAVE A NAIL GAMMA STUCK ON THE NAIL HOLDER." SALES REP REPORTED THAT: "YESTERDAY [SURGEON] PLACED A SHORT GAMMA NAIL ON A PATIENT, AND WHEN HE WANTED TO REMOVE THE NAIL HOLDER FROM THE NAIL, HE COULDN'T UNSCREW IT. HE OPENED ANOTHER ANCILLARY TO PUT ANOTHER NAIL IN."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10033570 ↗
• MalfunctionJan 22, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PHARMACIST REPORTED TO THE ANSM THE FOLLOWING EVENT : " DURING A SURGERY RELATED TO THE IMPLANTATION OF A GAMMA 3 NAIL, IT WAS IMPOSSIBLE TO RETRIEVE THE TARGET DEVICE. THE MEDICAL STAFF HAD TO RE-START THE SURGERY WITH ANOTHER DEVICE. THE UNLOCKING WAS FINALLY MADE BY A NURSE AT THE STERILIZATION. THE EXTRACTED NAIL AND THE TARGET DEVICE HAVE BEEN PLACED IN QUARANTINED "

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9616601 ↗
• MalfunctionDec 27, 2019Difficult to Remove; Mechanical Jam; Difficult or Delayed Separation; Difficult to Remove; Mechanical Jam; Difficult or Delayed Separation

  THE CUSTOMER REPORTED TO THE ANSM THAT : "THE INCIDENT OCCURRED DURING THE INTERVENTION WITH A GAMMA NAIL ONCE THE GAMMA NAIL WAS INSTALLED, IT WAS IMPOSSIBLE TO UNSCREW THE NAIL FROM THE TARGET DEVICE. IT WAS NECESSARY TO REPEAT THE WHOLE PROCEDURE WITH ANOTHER INSTRUMENT PANEL AND ONCE THE NAIL WAS EXTRACTED FROM THE TARGET DEVICE, THE LOCKING WAS COMPLETE AND IT WAS STILL IMPOSSIBLE TO UNSCREW IT. THE UNLOCKING HAD TO BE DONE IN STERILIZATION. THE EXTRACTED NAIL HAS BEEN QUARANTINED WITH THE TARGET DEVICE, A REPLACEMENT OF THE NAIL PORT HAS BEEN REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9527440 ↗
• MalfunctionOct 1, 2019Fracture; Difficult to Remove; Fracture

  AS REPORTED: "DURING AN INSERTION OF A LONG GAMMA NAIL, THE SURGEON NEEDED TO BACK OUT NAIL FOR CORRECT LAG SCREW POSITION. WHEN TRYING TO REMOVE NAIL HOLDING BOLT, SURGEON NOTICED BOLT WAS COMPROMISED. SURGEON STRUGGLED TO GET BOLT OFF TARGETER, SURGICAL TECH COULD NOT SEPARATE SLEEVE FROM TARGETER. SHE STATED TO ME IT WAS STUCK, SHE PULLED APART AND PLASTIC PIECES FLEW EVERYWHERE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9143471 ↗
• MalfunctionJun 13, 2019Fracture; Material Deformation; Break; Fracture; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT, DURING A PRIMARY PROCEDURE ON A LEFT FEMUR, WHEN IMPACTING THE GAMMA NAIL, THE HOLDING BOLT BROKE OFF IN THE PATIENT'S FEMUR. THE PIECE WAS REMOVED FROM THE PATIENT AND SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 25-30 MINUTES.

  Patient problems: No Code Available

  MAUDE report 8697598 ↗