NA 317.26Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587038438), received between Jun 1, 2023 and May 20, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

6 other recalls cover devices cleared under the same FDA submission (K043310); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2024, THE DRILL BIT BROKE. THE REMAINING DRILL WAS REMOVED AND THE PROCEDURE WAS FINISHED WITHOUT COMPLICATIONS. THERE WAS NO PATIENT HARM OR DELAY IN SURGERY. THIS REPORT IS FOR A 1.1MM DRILL BIT/MINI QC WITH 6MM STOP/44.5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19354889 ↗
• MalfunctionMay 15, 2024Break; Break

  IT WAS REPORTED DURING A SURGERY ON (B)(6) 2024 THE DRILL BIT BROKE INTRAOPERATIVELY. DURING SURGERY, THE DOCTOR ASKED HIS ASSISTANT PHYSICIAN TO MAKE HOLES IN THE BONE TABLE FOR PLACEMENT OF THE PLATES. IN THE FIRST HOLE MADE, THE DRILL BIT BROKE, WITH FRAGMENTS REMAINING INSIDE THE BONE. THE FRAGMENTS WERE ABLE TO BE REMOVED FROM THE PATIENT AND NO FRAGMENTS WERE RETAINED IN THE PATIENT. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS REPORT IS FOR ONE 1.1MM DRILL BIT/MINI QC WITH 6MM STOP/44.5MM FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19319405 ↗
• MalfunctionJun 1, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2023, A DRILL BIT BROKE DURING THE PROCEDURE. THE FRAGMENT WAS LOST. IT HAD NO NEGATIVE IMPLICATIONS FOR THE PATIENT. UPON PRODUCT RETURN, IT WAS NOTED THAT AN ADDITIONAL DRILL BIT WAS BROKEN. THIS REPORT INVOLVES ONE 1.1MM DRILL BIT/MINI QC WITH 6MM STOP/44.5MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037324 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K043310. One submission often covers many models, so check the product and lot details in each record.

• Z-0681-2017 · Nov 1, 2016 · Terminated
  Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
• Z-2783-2016 · Jun 24, 2016 · Terminated
  Light Adaptor for Small Battery Drive and Small Battery Drive II.
• Z-2784-2016 · Jun 24, 2016 · Terminated
  Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage: The Light Adaptor for Small Battery Drive (SBD) /Small Battery Drive II (SBD II) is designed for use in
• Z-2199-2016 · May 31, 2016 · Terminated
  Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments ar
• Z-1313-2015 · Dec 19, 2014 · Terminated
  Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticati
• Z-0615-2014 · Apr 15, 2013 · Terminated
  Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and met