NA 310.520Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10887587035192), received between Jul 25, 2022 and Sep 27, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT BEFORE AN ORTHOPEDIC PROCEDURE ON (B)(6) 2024 THE DRILL BIT DID NOT FIT IN OT AO QC POWER ATTACHMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20320474 ↗
• MalfunctionJul 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING A ORTHOPEDIC SURGERY, THE DRILL BIT DID NOT FIT INTO THE QUICK COUPLING ADAPTER FOR THE POWER EQUIPMENT. THIS REPORT IS FOR ONE (1) 1.8MM DRILL BIT/QC/125MM THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19722916 ↗
• MalfunctionJul 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING A ORTHOPEDIC SURGERY, THE DRILL BIT DID NOT FIT INTO THE QUICK COUPLING ADAPTER FOR THE POWER EQUIPMENT. THIS REPORT IS FOR ONE (1) 1.8MM DRILL BIT/QC/125MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19722469 ↗
• MalfunctionMay 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, THE DRILL BIT 1.8MM HAD A QUICK COUPLING WHICH WOULD NOT FIT INTO A DRILL QUICK COUPLING ATTACHMENT. A NEW DRILL BIT WAS SELECTED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 1.8MM DRILL BIT/QC/125MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19375774 ↗
• MalfunctionMar 20, 2024Defective Device; Device-Device Incompatibility; Defective Device; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING SURGERY, THE SCRUB TRIED TO LOAD THE DRILL BIT INTO THE AOO QUICK ATTACHMENT FOR THE DRILL, BUT THE DRILL BIT WOULD NOT FIT INTO THE QUICK CONNECT. IT WAS REPORTED THAT THE DRILL BIT WAS TOO WIDE TO FIT INTO THE ATTACHMENT. AFTER THE CASE, THE REP TRIED OTHER QUICK CONNECTS AND OTHER DRILL BITS TO INVESTIGATE, AND IT WAS DETERMINED THAT THE ISSUE WAS WITH THE DRILL BIT AND NOT ANY DRILL ATTACHMENTS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 2 MINUTES, USING A NEW DRILL BIT OF THE SAME TYPE. THERE WERE NO FRAGMENTS GENERATED, NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.8MM DRILL BIT/QC/125MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18943538 ↗
• MalfunctionFeb 14, 2024Defective Device; Device-Device Incompatibility; Defective Device; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE 1.8 DRILL BITS WERE MILLED TOO WIDE AND AREN'T ABLE TO FIT IN THE AO QUICK CONNECT DRILL. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 1.8MM DRILL BIT/QC/125MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT. (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18703110 ↗
• MalfunctionJan 18, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE DRILL BIT IN QUESTION WOULD NOT FIT INTO THE QUICK COUPLING ATTACHMENT. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.8MM DRILL BIT/QC/125MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18537070 ↗
• MalfunctionDec 8, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE 1.8 DRILL BIT THREADS APPEARED UNTWISTED AND THE TIP SNAPPED OFF. THIS REPORT INVOLVES ONE (1) 1.8MM DRILL BIT/QC/125MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15945114 ↗
• MalfunctionJul 25, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE 1.8 DRILL BIT THREADS APPEARED UNTWISTED AND THE TIP SNAPPED OFF. THIS REPORT INVOLVES ONE (1) DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15092871 ↗

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