NA 05.001.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 770 adverse event reports that list this exact device (DI 10886982128201), received between Nov 22, 2017 and Sep 25, 2026 — classified as 7 injuries, 763 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (477 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 25 most recent of 770 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Unintended System Motion; Complete Loss of Power

  It was reported that during service and evaluation, it was determined that the electric pen drive device had unintended activation/motion. It was further determined that the device failed pretest for Check for unintended motion. It was noted in the service order that the handpiece was not working properly. This event did not occur during a surgical procedure. There were no reports of injuries, medical intervention, or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a Supplemental MedWatch will be submitted accordingly.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896623 ↗
• MalfunctionSep 22, 2026Unintended System Motion; Intermittent Loss of Power

  It was reported that during service and evaluation, it was determined that the electric pen drive device had an unintended activation/motion. It was noted in the service order that the handpiece sometimes worked by itself and sometimes did not work. This event did not occur during surgery. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. However, it was reported that the event occurred in 2026. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853937 ↗
• MalfunctionSep 17, 2026Unintended System Motion

  It was reported that the ELECTRIC PEN DRIVE 60,000 RPM device started without pressing down on the HAND SWITCH FOR ELECTRIC PEN DRIVE device. It was not reported if the device was used in surgery. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50806207 ↗
• MalfunctionSep 16, 2026Unintended System Motion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50795330 ↗
• MalfunctionSep 15, 2026Excessive Heating

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778965 ↗
• MalfunctionSep 14, 2026Unintended System Motion; Device Markings/Labelling Problem; Complete Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50756879 ↗
• MalfunctionSep 14, 2026Excessive Heating

  This is report 1 of 3 for (b)(4).It was reported that during an unspecified surgical procedure, it was discovered that three electric pen drive devices heated up. There were no delays to the surgical procedure. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50753176 ↗
• MalfunctionSep 14, 2026Excessive Heating

  This is report 2 of 3 for (b)(4).It was reported that during an unspecified surgical procedure, it was discovered that three electric pen drive devices heated up. There were no delays to the surgical procedure. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50753171 ↗
• MalfunctionSep 14, 2026Excessive Heating

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50753167 ↗
• MalfunctionSep 10, 2026Unintended System Motion

  It was reported that the ELECTRIC PEN DRIVE device does not stop, it keeps spinning once latch is let go of. It was not reported if the device was used in surgery. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. However, it was reported that the event occurred in 2026.All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50714761 ↗
• MalfunctionSep 10, 2026Excessive Heating

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713702 ↗
• MalfunctionSep 1, 2026Appropriate Device Problem Term/Code Not Available; Fail-Safe Did Not Operate

  It was reported that during service and evaluation, it was determined that the electric pen drive device would run in the locked position. It was further determined that the device failed pretest for Check Handpiece in "LOCK" mode and Check function in FORWARD (FWD) and REVERSE (REV) running mode. It was noted in the service order that the device was defective. This event did not occur during surgery. There were no reports of injuries, medical intervention, or prolonged hospitalization. The exact date of the event was not reported; however, it was reported that the event occurred in 2026. All available information has been disclosed. If additional information should become available, a Supplemental MedWatch will be submitted accordingly.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50545840 ↗
• MalfunctionAug 26, 2026Unintended System Motion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50460398 ↗
• MalfunctionAug 21, 2026Unintended System Motion

  It was reported that during service and evaluation, it was determined that the ELECTRIC PEN DRIVE 60,000 RPM device had Unintended Activation/Motion. It was noted in the service order that the device needed repair, corrective maintenance. A specific malfunction was not reported. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50370153 ↗
• MalfunctionAug 18, 2026Excessive Heating

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50309043 ↗
• MalfunctionAug 12, 2026Unintended System Motion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50226338 ↗
• MalfunctionAug 6, 2026Unintended System Motion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50155131 ↗
• MalfunctionJul 28, 2026Unintended System Motion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50053481 ↗
• MalfunctionJul 27, 2026Device Reprocessing Problem; Unintended System Motion; Environmental Particulates; Excessive Heating

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50034886 ↗
• MalfunctionJul 27, 2026Unintended System Motion; Complete Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50017724 ↗
• MalfunctionJul 10, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ELECTRIC PEN DRIVE DEVICE EXPERIENCED UNINTENDED ACTIVATION/MOTION. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS FAULTY DURING REPROCESSING. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25779965 ↗
• MalfunctionMar 11, 2026Unintended System Motion; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE PEN DRIVE DEVICE HAD UNINTENDED ACTIVATION/MOTION IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT FUNCTIONING. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567571 ↗
• MalfunctionFeb 27, 2026Complete Loss of Power; Intermittent Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ELECTRIC PEN DRIVE DEVICE HAD INTERMITTENT OPERATION, AND MOVING PARTS OF THE DEVICE WERE NOT MOVING SMOOTHLY. IT WAS NOTED THAT THE HANDPIECE RUNS ON FORWARD AND REVERSE MODE WITHOUT BEING PROMPTED BUT STAYS OFF IN LOCKED MODE, THERE IS ALSO THE OCCASIONAL ROUGH RUNNING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR UNINTENDED MOTION AND CHECK GENERAL FUNCTION WITH TEST HAND SWITCH. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470919 ↗
• MalfunctionFeb 23, 2026Output below Specifications; Excessive Heating

  IT WAS REPORTED THAT THE ELECTRIC PEN DRIVE DEVICE WAS OVERHEATING AND SLOWING DOWN DURING USE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. THERE WERE NO REPORTS OF SURGICAL DELAY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24416234 ↗
• MalfunctionFeb 3, 2026Unintended System Motion

  IT WAS REPORTED THAT THE PEN DRIVE DEVICE MOTOR DEVICE OVERHEATED. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246557 ↗

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