NA 532.103Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982241177), received between Nov 20, 2017 and Feb 4, 2025 — classified as 1 death, 11 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (5 reports).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING SERVICE AND REPAIR/PRE-TESTING, IT WAS OBSERVED THAT THE SMALL BATTERY DRIVE DEVICE HAD COSMETIC DAMAGE, THE HOUSING WAS WORN, WAS LEAKING A LIQUID AND THE ETCHING WAS ILLEGIBLE. THE DEVICE ALSO FAILED PRETESTS FOR MARKING AND LABELING, GENERAL CONDITION AND LEVER FUNCTION AND CHECK FOR EXTERNAL CLEANNESS. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21306251 ↗
• MalfunctionJun 10, 2024Fire; Fire

  THIS IS REPORT 2 OF 3 FOR THE SAME EVENT. IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE COLIBRI HANDPIECE DEVICE WHILE BEING USED WITH A BATTERY DEVICE AND A CASING DEVICE, CAUGHT FIRE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS AVAILABLE FOR USE AND THAT THERE WERE NO PATIENT CONSEQUENCES. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19497193 ↗
• MalfunctionApr 26, 2022Break; Fracture; Leak/Splash; Break; Fracture; Leak/Splash

  IT WAS REPORTED FROM (B)(6) THAT THE BATTERY DEVICE WAS LEAKY. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. 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 14209880 ↗
• MalfunctionFeb 1, 2022Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY DEVICE FOR THE SMALL BATTERY DRIVE DEVICE WAS LEAKING LIQUID AND HAD COMPONENT DAMAGE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE 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. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2022. 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 13417258 ↗
• MalfunctionJun 3, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED FROM (B)(6) THAT THE SMALL BATTERY DRIVE LEAKED WHEN THE BATTERY WAS REMOVED FROM THE CHARGER. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11931816 ↗
• DeathMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 4 OF 4 FOR THE SAME EVENT: IT WAS REPORTED FROM (B)(6) THAT DURING A PROXIMAL HUMERAL FRACTURE SURGERY, WHILE USING A ¿NAIL (MDM PRODUCT)¿ AND THE CHUCK DEVICE, IT WAS DISCOVERED THAT AT THE TIME OF INSERTION OF THE LATERAL FIXATION SCREW, WHILE DRILLING THE PROXIMAL PART OF THE UPPER ARM, THE K-WIRE DEVICE (COMPETITORS¿ PRODUCT) FOR TEMPORARY FIXATION INTERFERED/HAD CONTACT WITH THE CHUCK, CAUSING THE K-WIRE TO ENTER THE BODY, AND REACHING THE PATIENT'S HEART. IT WAS REPORTED THAT THE PATIENT EXPIRED. THE EXACT DATE OF THE PATIENT¿S DEATH WAS NOT REPORTED. IT WAS REPORTED THAT THE BATTERY DEVICE WAS USED TOGETHER WITH THE SMALL BATTERY DRIVE DEVICE, BATTERY CASING DEVICE AND THE CHUCK DEVICE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WERE AVAILABLE FOR USE. THERE WERE NO REPORTS OF ANY ALLEGATION OF MALFUNCTION AGAINST THE DEVICES. THERE WAS PATIENT INVOLVEMENT REPORTED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT. THE REPORTER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THIS EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOM

  Patient problems: Cardiac Perforation

  MAUDE report 11797303 ↗
• MalfunctionFeb 15, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED FROM THE (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE BATTERY OF THE SMALL BATTERY DRIVE DEVICE STARTED TO HEAT AND THE RED BATTERY HOUSE WAS MELTING AND HAD BROKE OPEN. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR WHETHER A SPARE DEVICE WAS AVAILABLE FOR USE. 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 8342783 ↗
• MalfunctionDec 4, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THIS IS REPORT 3 OF 4 FOR THE SAME EVENT: IT WAS REPORTED THAT DURING A VETERINARY TIBIAL PLATEAU LEVELING OSTEOTOMY (TPLO) SURGERY ON A CANINE, IT WAS OBSERVED THAT THE SMALL BATTERY DRIVE DEVICE AND THREE BATTERY DEVICES WERE NOT WORKING WHILE BEING USED TOGETHER. THERE WAS A FIVE MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DRILL DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THE DEVICE WAS USED IN A VETERINARY 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7079766 ↗
• MalfunctionDec 4, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THIS IS REPORT 2 OF 4 FOR THE SAME EVENT: IT WAS REPORTED THAT DURING A VETERINARY TIBIAL PLATEAU LEVELING OSTEOTOMY (TPLO) SURGERY ON A CANINE, IT WAS OBSERVED THAT THE SMALL BATTERY DRIVE DEVICE AND THREE BATTERY DEVICES WERE NOT WORKING WHILE BEING USED TOGETHER. THERE WAS A FIVE MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DRILL DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THE DEVICE WAS USED IN A VETERINARY 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7079495 ↗
• MalfunctionDec 4, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THIS IS REPORT 4 OF 4 FOR THE SAME EVENT: IT WAS REPORTED THAT DURING A VETERINARY TIBIAL PLATEAU LEVELING OSTEOTOMY (TPLO) SURGERY ON A CANINE, IT WAS OBSERVED THAT THE SMALL BATTERY DRIVE DEVICE AND THREE BATTERY DEVICES WERE NOT WORKING WHILE BEING USED TOGETHER. THERE WAS A FIVE MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DRILL DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THE DEVICE WAS USED IN A VETERINARY 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7079473 ↗
• MalfunctionNov 20, 2017Device Inoperable; Device Operates Differently Than Expected; Device Inoperable; Device Operates Differently Than Expected

  THIS IS REPORT 8 OF 8 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE ACETABULUM, IT WAS OBSERVED THAT EIGHT LITHIUM BATTERY DEVICES WERE NOT CHARGING PROPERLY. IT WAS REPORTED THAT WHEN THE DEVICES WERE INSERTED INTO THE BATTERY CHARGER DEVICE THE AMBER LIGHT CAME ON INITIALLY, AND ABOUT 30 SECONDS LATER THE RED LIGHT CAME ON. IT WAS REPORTED THAT THERE WAS A 10 MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. 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 Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7046035 ↗
• MalfunctionNov 20, 2017Device Inoperable; Device Operates Differently Than Expected; Device Inoperable; Device Operates Differently Than Expected

  THIS IS REPORT 4 OF 8 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE ACETABULUM, IT WAS OBSERVED THAT EIGHT LITHIUM BATTERY DEVICES WERE NOT CHARGING PROPERLY. IT WAS REPORTED THAT WHEN THE DEVICES WERE INSERTED INTO THE BATTERY CHARGER DEVICE THE AMBER LIGHT CAME ON INITIALLY, AND ABOUT 30 SECONDS LATER THE RED LIGHT CAME ON. IT WAS REPORTED THAT THERE WAS A 10 MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. 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 Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7045898 ↗