NA 03.010.079Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982067494), received between Oct 31, 2018 and Jun 19, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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.

• MalfunctionJun 19, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT INSTRUMENTS WERE UNABLE TO BE STERILIZES/ASSEMBLES. CHIPPING AND CRACKING. UNABLE TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289769 ↗
• MalfunctionMar 29, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NEW (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STEPPED DRILL BIT AND DRILL STOP WERE SLIPPING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN HIP SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN), UNKNOWN LFN NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) DRILL STOP FOR 4.5MM/6.5MM STEPPED DRILL BIT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11582994 ↗
• InjuryFeb 4, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, THE DRILL STOP FOR 4.5MM /6.5MM STEPPED DRILL BIT IN THE FEMORAL RECON NAIL TRAY BROKE OFF IN THE FEMORAL HEAD OF THE PATIENT INTRAOPERATIVELY. TRIED TO RETRIEVE THE BROKEN BIT WITH THE PITUITARY. THERE WERE A FEW EXTRA X-RAYS TAKEN WHEN ATTEMPTING TO RETRIEVE THE BROKEN PIECE. THE BROKEN PIECE WAS LEFT IN THE FEMORAL HEAD. THERE WERE 10 MINUTES OF SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) DRILL STOP FOR 4.5MM/6.5MM STEPPED DRILL BIT. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11281682 ↗
• MalfunctionJan 28, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR AN INTRAMEDULLARY NAILING OF FEMUR SURGERY. DURING THE SURGERY, THE DRILL STOP WAS SLIDE TWICE IN THE SAME PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY REPORTED. THERE WERE NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: DRILL BIT (PART#: 03.010.078, LOT#: UNKNOWN, QUANTITY: 1), UNKNOWN SCREW (PART#: 03.010.078, LOT#: UNKNOWN, QUANTITY: 2). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT INVOLVES ONE (1)DRILL STOP FOR 4.5MM/6.5MM STEPPED DRILL BIT. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11247381 ↗
• MalfunctionJan 29, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF RIGHT FEMUR. DURING THE PROCEDURE, THE DRILL STOP AND THE STEPPED CANNULATED DRILL BIT WERE NOT LOCKING INTO PLACE. THE PROCEDURE SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A DRILL STOP FOR 4.5MM/6.5MM STEPPED DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8286857 ↗
• MalfunctionOct 31, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A FEMORAL RECON NAIL PROCEDURE ON (B)(6) 2018, THE DRILL STOP SLIPPED ON DRILL BIT WHILE DRILLING FOR UNKNOWN RECON SCREWS. THE DRILL STOP WOULD NO LONGER LOCKED INTO THE DRILL BIT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO PATIENT CONSEQUENCE REPORTED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN RECON SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY # UNKNOWN), UNKNOWN FEMORAL RECON NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) DRILL STOP FOR 4.5MM/6.5MM STEPPED DRILL BIT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8026212 ↗