NA 03.507.002SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10887587014166), received between Feb 14, 2019 and Jul 8, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (7 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 8, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6), 2025 THE 2.4 THREADED REDUCTION TOOL BROKE OFF IN PATIENT WHILE THE SURGEON WAS TRYING TO REDUCE ZMC FRACTURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22438448 ↗
• MalfunctionOct 23, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT ORIF FOR FACIAL FRACTURE ON (B)(6) 2024. THE THREAD REDUCTION TOOL BROKE DURING THE PROCEDURE. IT WAS DISCARDED IN THE SHARPS BIN.

  Patient problems: Insufficient Information

  MAUDE report 20514130 ↗
• InjuryJan 22, 2024Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THERE WAS A FAILURE OF DEVICE DURING USE. THE THREADED REDUCTION TOOL BROKE OFF INTO THE PATIENT'S BONE AND REQUIRED REMOVAL. A LARGER INCISION WAS REQUIRED TO BE MADE ON THE CHEEK OF THE PATIENT IN ORDER TO REMOVE THE BROKEN SCREW PORTION OF THE DEVICE. PROCEDURE WAS COMPLETED WITH A ONE HOUR DELAY. PATIENT IS CURRENTLY IN GOOD HEALTH. THIS REPORT IS FOR A 2.4MM THREADED REDUCTION TOOL SELF-DRILLING 78MM HEX-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18553917 ↗
• MalfunctionOct 3, 2023Break; Break

  IT WAS REPORTED THAT THE SURGEON REDUCED ZMC FX USING 2.4 THRD RED TOOL SELF-DRILLING 78 HEX-S. FX REDUCED AND WHILE MANIPULATING FOR FINE ADJUSTMENTS TO REDUCE THE FX A PORTION OF THE 2.4 THREADED REDUCTION TOOL BROKE OFF IN THE BONE. AFTER 40MIN MINIMUM THE END OF THE THREADED PORTION OF THE TOOL WAS REMOVED WITHOUT ANY COMPLICATION DELAYING THE CASE INTRAOPERATIVELY. THE PART HAS BEEN GIVEN. THERE WAS A PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) (B)(4). THIS IS REPORT 1 OF 1 FOR COMPLAINT 2.4 THRD RED TOOL SELF-DRILLING 78 HEX-S.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17861425 ↗
• MalfunctionJun 18, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE THREADED REDUCTION TOOL BREAK INSIDE THE PATIENT. THE BROKEN PART WAS RETRIEVED. THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12026590 ↗
• InjuryMar 13, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2020, THE 2.4MM THREADED REDUCTION TOOL SELF- DRILLING 78MM HEX -STERILE BROKE OFF IN THE PATIENT'S FACE. SWITCHED TO SELF-TAPPING CARROLL-GERARD, LEFT BROKEN PIECE IN THE PATIENT. THE SCREW WAS NOT REMOVED. NO FRAGMENTS GENERATED. THERE WERE 30 MINUTES OF SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - PLATES: MATRIXMID FACE (PART # UNKNOWN; LOT # UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: Foreign Body In Patient; Injury

  MAUDE report 9832209 ↗
• InjuryFeb 14, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A ZYGOMATIC FRACTURE, THE THREADED REDUCTION TOOL SELF-DRILLING BROKE OFF AS IT WAS ALREADY SCREWED INTO THE ZYGOMA. THE SURGEON HAD PREVIOUSLY USED IT TO MANIPULATE THE BONE, BUT IT WAS NOT BEING TOUCHED AT THE TIME IT BROKE. THE SURGEON WAS LOOKING AT PLATES AND THE TOOL BROKE OFF AND LANDED ON THE GROUND. PART OF THE SCREW WAS UNABLE TO BE ACCESSED FOR REMOVAL FROM THE PATIENT. FRAGMENTS WERE GENERATED AND WERE NOT ACCESSIBLE FOR REMOVAL. THERE WAS NO SURGICAL DELAY AND PATIENT CONSEQUENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 8341371 ↗