NA 316.451Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587038070), received between Aug 18, 2020 and Aug 18, 2020 — classified as 3 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. 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.

• MalfunctionAug 18, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DRILL BITS BROKE INTRAOPERATIVELY DURING A CRANIOPLASTY ON (B)(6) 2020. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY AND IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS NOTED DURING THE PROCEDURE THE DRILL BITS WERE REPLACED WITH NEW ONES WHEN THEY BROKE. THE DRILL BITS WERE TREATED AS DISPOSABLE ACCORDING TO THE MEDICAL STAFF. IT IS UNKNOWN IF ANY FRAGMENTS REMAINED IN THE PATIENT. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10419902 ↗
• MalfunctionAug 18, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DRILL BITS BROKE INTRAOPERATIVELY DURING A CRANIOPLASTY ON (B)(6) 2020. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY AND IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS NOTED DURING THE PROCEDURE THE DRILL BITS WERE REPLACED WITH NEW ONES WHEN THEY BROKE. THE DRILL BITS WERE TREATED AS DISPOSABLE ACCORDING TO THE MEDICAL STAFF. IT IS UNKNOWN IF ANY FRAGMENTS REMAINED IN THE PATIENT. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10419878 ↗
• MalfunctionAug 18, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DRILL BITS BROKE INTRAOPERATIVELY DURING A CRANIOPLASTY ON (B)(6) 2020. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY AND IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS NOTED DURING THE PROCEDURE THE DRILL BITS WERE REPLACED WITH NEW ONES WHEN THEY BROKE. THE DRILL BITS WERE TREATED AS DISPOSABLE ACCORDING TO THE MEDICAL STAFF. IT IS UNKNOWN IF ANY FRAGMENTS REMAINED IN THE PATIENT. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10419817 ↗

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-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-2783-2016 · Jun 24, 2016 · Terminated
  Light Adaptor for Small Battery Drive and Small Battery Drive II.
• 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