NA 05.001.063Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982128867), received between Nov 18, 2020 and Jul 8, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2026Device-Device Incompatibility; Excessive Heating

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25748061 ↗
• MalfunctionOct 6, 2023Excessive Heating; Excessive Heating

  IT WAS REPORTED FROM CHINA THAT DURING PRE-SURGERY, IT WAS DISCOVERED THAT THE TEMPERATURE FOR ATTACHMENT DEVICE WAS ABNORMALLY HIGH. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS AVAILABLE FOR USE. 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17889002 ↗
• MalfunctionSep 1, 2023Appropriate Device Problem Term/Code Not Available; Excessive Heating; Appropriate Device Problem Term/Code Not Available; Excessive Heating

  IT WAS REPORTED BY GERMANY THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BURR ATTACHMENT DEVICE HAD HEAT. IT WAS FURTHER OBSERVED THAT THE DEVICE DID NOT FUNCTION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR FUNCTION TEST. 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 2023. 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 17670419 ↗
• MalfunctionMar 31, 2023Appropriate Device Problem Term/Code Not Available; Excessive Heating; Appropriate Device Problem Term/Code Not Available; Excessive Heating

  IT WAS REPORTED BY GERMANY THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BURR ATTACHMENT DEVICE WAS GENERATING HEAT. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR FUNCTIONAL TEST. 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 2023. 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 16658923 ↗
• MalfunctionFeb 7, 2022Complete Loss of Power; Excessive Heating; Complete Loss of Power; Excessive Heating

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BURR ATTACHMENT DEVICE COULD NOT SECURE THE CUTTER DEVICE, OVERHEATED, MADE EXCESSIVE NOISE, THE ETCHING WAS ILLEGIBLE AND WORN. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR MARKING AND LABELING, TOOL COUPLING FOR CUTTING TOOL AND FUNCTION TEST. IT WAS NOTED IN THE SERVICE ORDER DID NOT WORK. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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 13471151 ↗
• MalfunctionOct 6, 2021Complete Loss of Power; Excessive Heating; Complete Loss of Power; Excessive Heating

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BURR ATTACHMENT DEVICE PRODUCED HEAT, EXCESSIVE NOISE, DID NOT FUNCTION, HAD COSMETIC DAMAGE-WORN ETCH AND AN ILLEGIBLE LABELING ETCH. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR MARKING & LABELING AND FUNCTION TEST. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK WHILE IN USE WITH AN AIR HOSE DEVICE, TWO BURR ATTACHMENT DEVICES AND A SAW ATTACHMENT/IN-LINE DEVICE. THIS EVENT DID NOT OCCUR DURING SURGERY. IT WAS REPORTED THAT THERE WERE NO DELAYS TO A SURGICAL PROCEDURE AND THE PROCEDURE WAS COMPLETED AS INTENDED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12581829 ↗
• MalfunctionJun 11, 2021Complete Loss of Power; Excessive Heating; Complete Loss of Power; Excessive Heating

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BURR ATTACHMENT DEVICE GENERATED HEAT AND MADE AN EXCESSIVE NOISE. IT WAS FURTHER OBSERVED THAT THE DEVICE DID NOT FUNCTION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR FUNCTION TEST. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. IT WAS REPORTED THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AND THE SURGERY WAS COMPLETED AS INTENDED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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 11984056 ↗
• MalfunctionJun 11, 2021Vibration; Complete Loss of Power; Excessive Heating; Vibration; Complete Loss of Power; Excessive Heating

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BURR ATTACHMENT DEVICE GENERATED HEAT AND EXPERIENCED VIBRATION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR FUNCTION TEST. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. IT WAS REPORTED THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AND THE SURGERY WAS COMPLETED AS INTENDED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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 11983858 ↗
• MalfunctionNov 18, 2020Vibration; Vibration

  IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE BURR ATTACHMENT DEVICE HAD A CONNECTION ISSUE. ACCORDING TO THE REPORTER, UNDER LOW SPEED CONDITION, THE ATTACHMENT WAS SWAYING. IT WAS FURTHER REPORTED THAT THE CUTTER DEVICE VIBRATED MILDLY ONCE IT WAS INSERTED INTO THE ATTACHMENT DEVICE AND THE MOTOR WAS STARTED. THERE WERE NO REPORTS OF DELAYS TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO 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 Consequences Or Impact To Patient

  MAUDE report 10864340 ↗

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