NA 2351-4213SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327350289), received between Aug 7, 2023 and Feb 6, 2026 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2026Fracture

  THE CUSTOMER REPORTED THAT: "WHILE WASHING THE ANCILLARY EQUIPMENT IN STERILIZATION, THE STERILIZATION AGENT NOTICED THAT A PIECE WAS MISSING FROM THE T2 ALPHA STRYKER DRILL REF (B)(4). CHECK THE PATIENT'S X-RAY, WHERE YOU CAN SEE THE PIECE OF DRILL NEXT TO THE SCREW. NO REOPERATION IN THE OPERATING ROOM IS NECESSARY, ACCORDING TO THE SURGEON. PATIENT DISCHARGED ON (B)(6) 2026 WITH NO COMPLICATIONS SO FAR. NO INTERVENTION TO REMOVE THE TIP IS NECESSARY AT THIS TIME.".

  Patient problems: Foreign Body In Patient

  MAUDE report 24280477 ↗
• InjuryJun 6, 2024Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED: "2 DRILL BITS BROKE DURING A FEMORAL NAIL PROCEDURE. THE PIECES OF DRILL BIT REMAINED IN THE PATIENT WITHOUT CONSEQUENCE."

  Patient problems: Foreign Body In Patient

  MAUDE report 19477289 ↗
• InjuryJun 6, 2024Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED: "2 DRILL BITS BROKE DURING A FEMORAL NAIL PROCEDURE. THE PIECES OF DRILL BIT REMAINED IN THE PATIENT WITHOUT CONSEQUENCE.".

  Patient problems: Foreign Body In Patient

  MAUDE report 19477177 ↗
• MalfunctionDec 1, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A TIBIAL NAIL PROCEDURE, DRILL BIT BROKE OFF AT TIP. MULTIPLE ATTEMPTS MADE TO RETRIEVE, BUT UNSUCCESSFUL. RETAINED DRILL BIT IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18246760 ↗
• MalfunctionSep 29, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "THE SHORT ALPHA DISTAL LOCKING DRILL SNAPPED AT THE TIP DURING THE DRILLING OF THE DISTAL SCREWS IN A T2 ALPHA TIBIAL NAIL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17847853 ↗
• MalfunctionAug 21, 2023Break; Fracture; Noise, Audible; Break; Fracture; Noise, Audible

  AS REPORTED: "WHEN DRILLING FOR 2ND LOCKING SCREW IN MOST DISTAL M/L HOLE A NOTABLE CHATTER COULD BE HEARD. FOLLOWING WHICH THE TIP OF THE DRILL BROKE OFF WHERE IT TAPERS DOWN AND TIP FRAGMENT WAS THEN SITUATED ON THE MEDIAL SIDE OF THE NAIL WITHIN THE PATIENT. BROKEN DRILL WAS REMOVED AND THE DECISION WAS MADE TO LEAVE THE TIP FRAGMENT IN SITU. SECOND DISTAL LOCKING WAS THEN PERFORMED USING THE A/P HOLE AND A NEW DRILL FROM THE SAME LOT WITH NO ISSUES."

  Patient problems: Foreign Body In Patient

  MAUDE report 17584665 ↗
• MalfunctionAug 7, 2023Off-Label Use; Mechanical Jam; Off-Label Use; Mechanical Jam

  AS REPORTED: "THE SERVICE&REPAIR CENTER IN THE NETHERLANDS REPORTED A STRYKER DRILL BIT FOUND STUCK IN A DEPUY SYNTHES ATTACHMENT. THE ATTACHMENT ISN'T WORKING PROPERLY; THE CUSTOMER DIDN'T PROVIDE FURTHER INFORMATION.¿

  Patient problems: Insufficient Information

  MAUDE report 17470516 ↗