NA 387.661Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982197719), received between Mar 23, 2018 and Dec 18, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT WAS SUCCESSFULLY TREATED. THERE WAS A 2 MINUTES DELAY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839762 ↗
• MalfunctionJul 2, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING A BONE GRAFT WITH THE TREPHINE IT WAS NOTICED THAT THE PATIENTS BONE QUALITY WAS VERY DENSE. TO TAKE THE BONE GRAFT, THE SURGEON DECIDED TO IMPACT THE TREPHINE WHICH CAUSED THE TREPHINE TO BREAK. THE FRAGMENTS WERE EASILY REMOVED. THERE WAS NO REPORTED SURGICAL DELAY. THE SURGERY CONTINUED AND WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED IMPACT TO THE PATIENT. THIS REPORT INVOLVES ONE (1) TREPHINE ATTACHMENT 10.5MM DIAMETER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10223822 ↗
• InjuryMar 20, 2020Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING AN EXTRACTION OF A BONE GRAFT IN THE LEFT FEMUR, WITH SUSPICION OF A OSTEOSARCOMA, THAT THE TOOTH OF THE TREPHINE ATTACHMENT 10.5 MM BROKE OFF DURING THE DRILLING/ MILLING STEP. THE FRAGMENT REMAINED IN THE BONE OF THE PATIENT. THIS REPORT IS FOR ONE TREPHINE ATTACHMENT 10.5MM DIAMETER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Injury; No Code Available

  MAUDE report 9861355 ↗
• MalfunctionFeb 26, 2020Break; Break

  UPDATED EVENT: THE SCREWS WERE REMOVED IN ORDER TO REMOVE THE ENDOMEDULAR NAIL, DUE TO OSTEOMYELITIS IN THE LOWER LEFT LIMB. AFTER SEVERAL ATTEMPTS TO REMOVE THE SCREWS, THE WERE ABLE TO BE REMOVED FROM THE NAIL WITH DIFFERENT CLAMPS AND EVEN WITH ANOTHER CALIBER OF TREPHINE. THE OTHER TREPHINES WERE USED TO ACHIEVE REACH THE SCREW THE RIA SYSTEM WAS SUBSEQUENTLY USED. THE INFECTION HAD BEEN DISCOVERED DURING PREVIOUS EXAMS AND THE PATIENT PRESENTED WITH PAIN, INFLAMMATION, AND SECRETIONS. THE ORIGINAL SURGERY OCCURRED APPROXIMATELY ONE (1) YEAR PRIOR TO THE FEBRUARY 6TH REVISION SURGERY. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 4), UNKNOWN TREPHINE EXTRACTOR (PART # UNKNOWN LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN ENDOMEDULAR NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1).

  Patient problems: No Code Available

  MAUDE report 9758410 ↗
• InjuryOct 12, 2018Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018. AFTER THE SURGERY, TWO (2) TREPHINE ATTACHMENTS WERE FOUND TO HAVE A MISSING TOOTH. THE SURGEON WAS INFORMED, AND AN X-RAY WAS DONE. IT WAS DISCOVERED THAT ONE PIECE WAS RETAINED IN THE PATIENT. THE SURGEON DECIDED TO LEAVE THE PIECE IN THE PATIENT. PATIENT CONSEQUENCE IS UNKNOWN. THIS REPORT IS FOR A TREPHINE ATTACHMENT 10.5MM DIAMETER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7962188 ↗
• MalfunctionMar 23, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE TREPHINE-ATTACHMENT BROKE DURING FIRST USE. NO OTHER INFORMATION PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7366639 ↗