NA 2351-4236SRecalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 07613327350241), received between May 3, 2022 and Sep 30, 2026 — classified as 25 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Fracture” (51 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 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Align

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952922 ↗
• MalfunctionSep 30, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952791 ↗
• MalfunctionSep 29, 2026Fracture

  Patient problems: Insufficient Information

  MAUDE report 50939509 ↗
• MalfunctionSep 24, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876496 ↗
• MalfunctionSep 21, 2026Fracture

  As reported: "The sales representative attended a Gamma4 procedure at the facility.Both the implant and instrumentation were long-term loan products that had been stored by the hospital. Upon arrival, the surgeon had already selected the implant to be used, and the nail (Gamma4 Intermediate Nail, Right) had already been opened according to the surgeon's instruction.The instrumentation used in this system can be configured for either the right or left side. Based solely on the implant provided and without independently verifying the operative side of the patient, the sales representative instructed that the instrumentation be assembled in the right-side configuration. Compatibility checks between the instrumentation and drill were completed, and the procedure initially progressed without issue.During distal locking screw fixation, interference occurred between the nail and the drill, resulting in breakage of the drill tip within the nail hole. Removal of the broken drill fragment was difficult. As an alternative, the surgeon elected to place a locking screw in the most distal hole; however, interference occurred again during the subsequent drilling attempt.Because the degree of misa

  Patient problems: Foreign Body In Patient

  MAUDE report 50841129 ↗
• MalfunctionSep 14, 2026Fracture

  Patient problems: Insufficient Information

  MAUDE report 50765049 ↗
• MalfunctionSep 11, 2026Fracture

  A drill was being used to place a distal transverse screw through the DTS, but the sleeve slipped due to soft tissue.When the direction of the drill was changed in an attempt to force it in, the drill broke. The broken piece was removed from the patient body.The procedure was completed drilled into a different screw hole with a new drill.

  Patient problems: Insufficient Information

  MAUDE report 50736916 ↗
• InjuryJul 28, 2026Fracture

  As reported: "Initially, when drilling on the proximal side of the transverse screw, the drill bit came into contact with the nail; the surgeon immediately checked and adjusted the position of the device using a lateral view, and after the drilling was re-started, the proximal screw was inserted without any problems.Next, when drilling the distal elliptical hole, there was again interference with the nail. As with the proximal screw, the surgeon checked and corrected the position using a lateral view, then drilled again; however, the medial cortex was extremely hard, and the drill bit broke when pressure was applied.As the drill bit remained embedded in the bone and was deemed impossible to extract, the surgery was completed while the broken drill bit was left in the patient's bone.".

  Patient problems: Foreign Body In Patient

  MAUDE report 50061362 ↗
• MalfunctionJul 20, 2026Failure to Align

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25881543 ↗
• InjuryJun 24, 2026Fracture

  IN A GAMMA4 LONG NAIL CASE, THE LOCKING DRILL CAME INTO CONTACT WITH THE NAIL DURING DISTAL DRILLING, CAUSING THE TIP TO BREAK. FRAGMENTS REMAINED IN THE PATIENT'S BODY. THE SURGEON DETERMINED THERE WERE NO PROBLEMS AND THE SURGERY WAS COMPLETED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25604491 ↗
• MalfunctionMay 12, 2026Fracture; Failure to Align

  AS REPORTED: "DURING DISTAL DRILLING, THE DRILL BIT WAS SLIGHTLY IN CONTACT WITH THE NAIL; THE DRILL TIP BROKE OFF THE MOMENT THE DEVICE WAS LOWERED FORCEFULLY. THE BROKEN DRILL TIP HAS BEEN REMOVED, SO THERE ARE NO FOREIGN BODIES REMAINING IN THE BODY." ADDITIONAL INFORMATION RECEIVED FROM SALES REP: HOW WAS THE ISSUE SOLVED? ANOTHER DRILL BIT WAS PROVIDED, AND THE ISSUE WAS RESOLVED BY MAKING MINOR ADJUSTMENTS TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25153055 ↗
• MalfunctionMay 12, 2026Failure to Align

  AS REPORTED: "DURING THE SHORT NAIL SURGERY, THE DRILL USED TO INSERT THE DISTAL SCREW SLIPPED OUT OF THE HOLE. THE SURGEON RE-DRILLED THE SITE AND SUCCESSFULLY INSERTED THE SCREW. AN UNNECESSARY HOLE WAS DRILLED IN THE BONE".

  Patient problems: Perforation

  MAUDE report 25153053 ↗
• MalfunctionApr 7, 2026Fracture

  AS REPORTED: "DURING SURGERY TO INSERT A T2 ANKLE NAIL, A 4.2 MM DRILL BIT BROKE AT BOTH THE PROXIMAL AND DISTAL FIXATION SCREW INSERTION SITES AFTER COMING INTO CONTACT WITH THE NAIL. THIS RESULTED IN THE BREAKAGE OF TWO DRILL BITS. AS THE HOSPITAL HAD A GMMA4 FIXATION DRILL OF THE SAME DIAMETER IN STOCK, THIS WAS USED AS A SUBSTITUTE TO COMPLETE THE OPERATION."

  Patient problems: Insufficient Information

  MAUDE report 24808034 ↗
• InjuryMar 30, 2026Fracture

  AS REPORTED: "SMALL 1 MM BROKEN DRILL BIT INSIDE THE BONE NOTED. NO HARM CAUSED. TOO RISKY AND INCREASEDDAMAGE IF TRIED TO TAKE OUT WITH NO CLEAR BENEFIT."

  Patient problems: Foreign Body In Patient

  MAUDE report 24714907 ↗
• InjuryFeb 12, 2026Fracture

  IT WAS REPORTED THAT "THE DRILL BROKE DURING DRILLING TO INSERT THE DISTAL TRANSVERSE SCREW. IT REMAINED INSIDE THE BODY." THIS EVENT HAPPENED DURING A PRIMARY SURGERY AND THE PATIENT WAS REPORTED TO BE A MAN IN HIS 60S. THE SURGERY WAS COMPLETED WITH THE DRILL STILL INSIDE THE BODY. NO PRODUCTS WILL BE RETURNED SINCE IT WAS DISCARDED AT THE HOSPITAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 24328428 ↗
• InjuryDec 29, 2025Fracture; Fracture

  AS REPORTED: "IT WAS REPORTED THAT WHILE THE SURGEON WAS DRILLING A DISTAL SCREW HOLE IN THE GAMMA NAIL, THE 4.2 MM DRILL BIT BROKE OFF INSIDE THE HOLE. THE SURGEON WAS UNABLE TO RETRIEVE THE BROKEN DRILL BIT PIECE AND CHOSE TO LEAVE IT INSIDE THE GAMMA NAIL HOLE. AN X-RAY WAS TAKEN AND THE SURGEON STATED THAT THE BROKEN DRILL BIT PIECE ARE QUITE STACKED AND WOULD NOT BE ABLE TO MIGRATE.".

  Patient problems: Foreign Body In Patient

  MAUDE report 23917958 ↗
• MalfunctionDec 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT "DURING DRILLING TO INSERT THE DISTAL LOCKING SCREW, THE DRILL BIT BROKE OFF. THE NEW DRILL WAS UNPACKED AND USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY."

  Patient problems: Insufficient Information

  MAUDE report 23769379 ↗
• InjuryNov 19, 2025Fracture; Fracture

  AS REPORTED: "A LOCKING DRILL WAS BROKEN DURING LATERAL STOP DRILLING WITH A T2 ALPHA GT NAIL. THE BROKEN DRILL WAS LEFT IN THE SCREW HOLE BY THE PHYSICIAN'S DECISION AND THE OPERATION WAS COMPLETED."

  Patient problems: Foreign Body In Patient

  MAUDE report 23600215 ↗
• MalfunctionNov 7, 2025Fracture; Fracture

  AS REPORTED: "WHILE DRILLING INTO THE DISTAL SCREW HOLE, THE DRILL PASSED THROUGH THE SCREW HOLE, BUT WHEN IT WAS ADVANCED FURTHER WHILE HOLDING THE DEVICE, IT BROKE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496236 ↗
• MalfunctionOct 31, 2025Fracture; Fracture

  THE CUSTOMER REPORTED THAT: "WHEN INSERTING A NAIL, USING THE SINGLE-USE DRILL BIT IN THE SIGHT DESIGNED TO BE INSERTED INTO THE NAIL (ALSO STYKER), THE DRILL BIT MADE A GRINDING NOISE AND BROKE. THE SURGEON RETRIEVED THE BROKEN DRILL BIT TIP. NEW DRILL BIT USED. NO CONSEQUENCES FOR THE PATIENT. PROLONGED OPERATING TIME. WE WERE SCREWING INTO A NAIL, SO IT WAS MORE LIKE A DRILL BIT AGAINST METAL (THROUGH THE TARGET DEVICE PROVIDED FOR THIS PURPOSE)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439078 ↗
• InjuryOct 29, 2025Fracture; Fracture

  AS REPORTED: "WHILE DRILLING T2AGT DISTAL OVAL HOLE, THE DRILL WAS GOING THROUGH THE SCREW HOLE BUT THE DRILL WAS NOT ADVANCING PROPERLY, AND THE DRILL TIP BROKE OFF WHEN THE PHYSICIAN CHANGED DIRECTION AND ADVANCED THE DRILL. THE TIP OF THE DRILL REMAINED IN THE PATIENTS BODY."

  Patient problems: Foreign Body In Patient

  MAUDE report 23415769 ↗
• MalfunctionSep 2, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "THE DRILL BROKE WHILE DRILLING TO THE DISTAL LATERAL LOCKING HOLE OF THE GAMMA4 LONG NAIL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22944793 ↗
• MalfunctionSep 2, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "THE DRILL BROKE WHILE DRILLING TO THE DISTAL LATERAL LOCKING HOLE OF THE GAMMA4 LONG NAIL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22944777 ↗
• MalfunctionJul 11, 2025Failure to Align; Material Deformation; Failure to Align; Material Deformation

  AS REPORTED: "WHEN THE DISTAL LOCKING SCREW OF THE TROCHANTERIC NAIL WAS INSERTED AFTER DRILLING, THE SCREW HIT THE DISTAL PART OF THE NAIL. IT SEEMED THAT THE SCREW HAD COME OFF DURING DRILLING. THE SURGEON OPENED ANOTHER DRILL AND RE-DRILLED, AND IT PASSED THROUGH THE NAIL WITHOUT ANY PROBLEMS. THE SCREW WAS THEN REINSERTED AND THE OPERATION WAS COMPLETED SUCCESSFULLY. THE FIXATION OF THE NAIL AND TARGET DEVICE HAS BEEN CONFIRMED. THERE WAS SLIGHT IMPACTION WHEN INSERTING THE NAIL. BOTH THE DRILL THAT WENT OUT AND THE DRILL THAT WENT THROUGH WITHOUT PROBLEMS WERE CHECKED AFTER THE SURGERY. WHEN COMPARING THE TIPS OF THE DRILLS, THERE WAS A SUBTLE DIFFERENCE IN THE SHAPE OF THE CUTTING EDGE." ADVERSE CONSEQUENCE: THE BONE DAMAGE DUE TO DRILL WAS OUT OF THE NAIL HOLE.

  Patient problems: Insufficient Information

  MAUDE report 22479167 ↗
• InjuryJul 10, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "DRILL 1: THE SURGEON MISTOOK THE SHORT NAIL FOR A LONG NAIL AND PROCEEDED TO DRILL INTO A SCREW HOLE THAT THE SHORT NAIL DID NOT HAVE. THE DRILL TIP WAS BROKEN AND THE TIP REMAINS IN THE PATIENT'S BODY, BUT THERE ARE NO PLANS TO REMOVE IT. DRILL 2: WHEN DRILLING INTO THE PROXIMAL SCREW HOLE, THE PATIENT'S MEDULLARY CAVITY WAS NARROW AND THE NAIL FLEXED, RESULTING IN INACCURATE TARGETING, WHICH CAUSED THE DRILL TO CONTACT THE NAIL AND BREAK OFF. THE TIP DOES NOT REMAIN IN THE PATIENT'S BODY."

  Patient problems: Foreign Body In Patient

  MAUDE report 22473563 ↗