NA 310.530Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587035239), received between May 30, 2019 and Jun 20, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING DRILLING, THE DRILL BIT BROKE. THE BROKEN DISTAL PART OF THE DRILL WAS LEFT IN THE PATIENT'S BONE. PROCEDURE WAS COMPLETED WITH NO DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22297469 ↗
• MalfunctionAug 25, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS DRILL BROKE IN THE SURGERY AND WAS NOT RETURNED IN THE LOAN SET TO THE LOCAL DC PATIENT OUTCOME/ CONSEQUENCES IS UNKNOWN. THIS REPORT IS FOR ONE DRILL BIT Ø2.4 L100/75 2FLUTE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15298862 ↗
• InjuryMay 30, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE WHILE DOING A TOTAL HIP ARTHROPLASTY, THE SURGEON WAS DRILLING SOME HOLES FOR SUTURE PASSING. THE DRILL BIT ENDED UP BREAKING AND REMAINS IN THE PATIENT. ADDITIONALLY, SURGEON STATED THAT THE FLUTES ON THE DRILL BIT HAVE A WEIRD PATTERN. THEY ARE NOT BARBER POLED LIKE MOST DRILL BITS. THERE WERE FRAGMENTS GENERATED, THEY ARE NOT REMOVED, AND NO ADDITIONAL INTERVENTION PERFORMED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8654434 ↗

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