NA 03.130.300Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982075574), received between Oct 18, 2018 and Mar 19, 2026 — classified as 1 injury, 7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Failure to Cut

  IT WAS REPORTED THAT DRILL BIT Ø1.5 L88/57 F/CORE HOLE, 1.5 DRILL BIT/MQC FOR THREADED HOLE/74, 2.0 DB/K-WIRE ATTCHMT GLIDING HOLE/71, AND DRILL BIT Ø2 L57/41 F/GLIDING HOLE WERE DULL AND NO LONGER FUNCTIONING TO THEIR OPTIMAL DRILLING CAPACITY DURING SURGERY. THESE COMPONENTS WERE DEEMED NON-FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED, WITH REPLACEMENTS REQUIRED. THERE WAS NO REPORTED PATIENT OR USER HARM, AND NO SIGNIFICANT DELAY OCCURRED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638403 ↗
• MalfunctionMar 19, 2026Failure to Cut

  IT WAS REPORTED THAT DRILL BIT Ø1.5 L88/57 F/CORE HOLE, 1.5 DRILL BIT/MQC FOR THREADED HOLE/74, 2.0 DB/K-WIRE ATTCHMT GLIDING HOLE/71, AND DRILL BIT Ø2 L57/41 F/GLIDING HOLE WERE DULL AND NO LONGER FUNCTIONING TO THEIR OPTIMAL DRILLING CAPACITY DURING SURGERY. THESE COMPONENTS WERE DEEMED NON-FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED, WITH REPLACEMENTS REQUIRED. THERE WAS NO REPORTED PATIENT OR USER HARM, AND NO SIGNIFICANT DELAY OCCURRED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638400 ↗
• MalfunctionAug 4, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING THE PROCEDURE AT THE TIME OF DRILLING, A 1.5MM DRILL BIT BROKE LEAVING A SMALL FRAGMENT OF IT INSIDE THE PATIENT'S BONE. SURGEON DECIDED TO LEAVE THIS FRAGMENT BECAUSE OF THE DIFFICULT EXTRACTION. ANOTHER BIT OF THE SAME DIAMETER AND OF THE SAME CHARACTERISTICS WAS USED TO FINISH THE SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22708244 ↗
• MalfunctionAug 26, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING THE PROCEDURE ON (B)(6) 2024, WHEN THE SURGEON WAS DRILLING THE BONE, THE DRILL BITS ARE BROKEN AND REMAINED IMPLANTED IN THE PATIENT. THERE WAS NO PATIENT IMPACT. THE CX WAS COMPLETED WITHOUT ANY SETBACKS. THIS REPORT IS FOR ONE (1) 1.5MM DRILL BIT/K-WIRE ATTACHMENT FOR THREADED HOLE/88MM THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 20067590 ↗
• MalfunctionAug 26, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING THE PROCEDURE ON (B)(6) 2024, WHEN THE SURGEON WAS DRILLING THE BONE, THE DRILL BITS ARE BROKEN AND REMAINED IMPLANTED IN THE PATIENT. THERE WAS NO PATIENT IMPACT. THE CX WAS COMPLETED WITHOUT ANY SETBACKS. THIS REPORT IS FOR ONE (1) 1.5MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/88MM. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 20067507 ↗
• InjuryFeb 24, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2022 THE DRILL BIT BROKE DURING USE. THE ROOM AND STERILE FIELD WAS SEARCHED BUT THE BROKEN PIECE WAS NOT FOUND. BASED ON THE X-RAY IMAGE THE SURGEON BELIEVED THAT THE BROKEN PIECE WAS INSIDE THE PATIENT. THE REMAINING BROKEN DRILL BIT WAS SENT DOWN TO STERILE PROCESSING DEPARTMENT (SPD) FOR CLEANING AND RISK MANAGEMENT. THIS REPORT IS FOR ONE (1) DRILL BIT Ø1.5 L88/57 F/CORE HOLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16436694 ↗
• MalfunctionNov 16, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE DRILL BIT WAS FRACTURED, AND THE PIECE OF THE TIP WAS LOST. IT WAS UNKNOWN IF THE LOST PIECE WAS REMAINS IN PATIENT. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES (1) DEVICE. THIS REPORT IS FOR (1) UNK ¿ PLATES. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12822224 ↗
• MalfunctionOct 18, 2018Break; Break

  IT WAS REPORTED THAT DURING A HAND SURGERY PROCEDURE ON (B)(6) 2018, THE TIP OF THE DRILL BIT K-WIRE ATTACHMENT FOR THREADED HOLE IN THE VARIABLE ANGLE (VA) HAND SET BROKE OFF. THE DRILL BIT WAS CONNECTED TO THE STRYKER POWER USING A JACOBS CHUCK. THE BROKEN FRAGMENTS OF THE DRILL BIT WERE RECOVERED USING AN UNKNOWN NEEDLE DRIVER AND ANOTHER DRILL BIT K-WIRE WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO SURGICAL DELAY AND PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS STABLE. CONCOMITANT DEVICES REPORTED: STRYKER POWER (PART #: UNKNOWN, LOT #: UNKNOWN, QUALITY #: 1), JACOBS CHUCK (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY #: 1). THIS REPORT IS FOR ONE (1) 1.5MM DRILL BIT/K-WIRE ATTACHMENT FOR THREADED HOLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7980090 ↗