NA 532.132Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10886982241207), received between Jan 9, 2018 and Aug 4, 2025 — classified as 1 death, 18 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (9 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. 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A PROXIMAL HUMERUS OSTEOSYNTHESIS WITH PHILOS PLATE PROCEDURE, IT WAS DISCOVERED THAT THE SMALL BATTERY DRIVE CASING DEVICE WAS CONSTANTLY BEING RELEASED FROM THE HANDPIECE DEVICE. THE PROCEDURE WAS DELAYED, THOUGH THE EXACT DURATION OF THE DELAY WAS NOT SPECIFIED. A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. 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 22702197 ↗
• MalfunctionDec 10, 2024Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Premature Separation; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Premature Separation

  IT WAS REPORTED THAT SMALL BATTERY DRIVE CASING DEVICE HAD A CONNECTIVITY ISSUE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS OBSERVED THAT THE DEVICE HAD UNINTENDED/UNEXPECTED DISENGAGEMENT. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FUNCTION AND CONTACTING WITH HANDPIECE. 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 FOR USE. 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 20891535 ↗
• MalfunctionJun 10, 2024Fire; Fire

  THIS IS REPORT 3 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 19497195 ↗
• MalfunctionAug 17, 2023Fire; Excessive Heating; Fire; Excessive Heating

  HIS IS REPORT 3 OF 3 FOR THE SAME EVENT. IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE COLIBRI HANDPIECE DEVICE BECAME SIGNIFICANTLY HEATED. SUBSEQUENTLY, A SUDDEN FLASH AND CRACKING SOUND OCCURRED EITHER WITHIN THE MACHINE OR THE BATTERY DRIVE DEVICE. THE CONNECTORS SURROUNDING THE HOUSING, AS WELL AS THOSE WITHIN THE DRILL, HAD BECOME CHARRED. IT WAS REPORTED THAT NEITHER THE PATIENT NOR THE STAFF WERE HARMED AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY ISSUES. IT WAS REPORTED THAT A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS REPORTED THAT THE DEVICES WERE BEING USED WITH A BATTERY CASING DEVICE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2023. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17565967 ↗
• MalfunctionAug 8, 2023Component Missing; Separation Failure; Premature Separation; Component Missing; Separation Failure; Premature Separation

  IT WAS REPORTED FROM FRANCE THAT THE BATTERY HOLDER OF THE SMALL BATTERY DRIVE DEVICE WAS INADVERTENTLY DISASSEMBLED, AND THE SILICONE SEAL WAS MISSING. IT WAS REPORTED THAT THEREFORE THE DEVICE NO LONGER PROVIDES WATERTIGHTNESS. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A DELAY TO A PLANNED PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE AVAILABLE FOR USE. THERE WAS NO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17480469 ↗
• MalfunctionNov 18, 2022Premature Separation; Premature Separation

  THIS IS REPORT 2 OF 2 OF THE SAME EVENT IT WAS REPORTED FROM (B)(6) THAT THE SMALL BATTERY DRIVE CASING DEVICE WAS COMING OFF THE SMALL BATTERY DRIVE DEVICE. 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. 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 15826124 ↗
• MalfunctionSep 14, 2022Appropriate Device Problem Term/Code Not Available; Premature Separation; Appropriate Device Problem Term/Code Not Available; Premature Separation

  IT WAS REPORTED FROM SINGAPORE THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SMALL BATTERY DRIVE DEVICE HAD UNINTENDED/UNEXPECTED DISENGAGEMENT AND COMPONENT DAMAGE. IT WAS ALSO OBSERVED THAT THE DEVICE CASING WAS UNABLE TO ATTACH TO HANDPIECE DEVICE AS THE PINS WERE BROKEN. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETESTS FOR FUNCTION OF BATTERY CASING COVER AND CONNECTION BATTERY CASING TO HANDPIECE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. 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 15419605 ↗
• MalfunctionSep 20, 2021Fire; Appropriate Device Problem Term/Code Not Available; Excessive Heating; Fire; Appropriate Device Problem Term/Code Not Available; Excessive Heating

  THIS IS REPORT 2 OF 2 OF THE EVENT. IT WAS REPORTED FROM FRANCE THAT DURING PRE-SURGERY, WHILE THE SURGEON WAS PREPARING THE DEVICES FOR THE PROCEDURE, IT WAS DISCOVERED THAT THE SMALL BATTERY DRIVE DEVICE STOPPED WORKING WHILE IN USE WITH THE BATTERY CASING DEVICE. ACCORDING TO THE REPORTER, WHEN THE SURGEON PUT THE BATTERY DEVICE INSIDE THE MOTOR DEVICE, IT PRODUCED SPARKS AND A LOT OF SMOKE AND WAS SMELLING OF BURN. AFTER THAT, THE MOTOR DID NOT TURN ON ANYMORE. ANOTHER BATTERY DEVICE WAS TRIED, HOWEVER THE DEVICE STILL DID NOT WORK AND IT WAS SMELLING OF BURN. IT WAS NOTED THAT BIOMED DID NOT KNOW IF THE PROBLEM WAS COMING FROM THE SMALL BATTERY DRIVE DEVICE OR THE BATTERY CASING DEVICE SO BOTH DEVICES WILL BE RETURNED. HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE BATTERY CASING DEVICE WOULD NOT BE RETURNED FOR FURTHER INVESTIGATION. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO 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 AVAILAB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12495442 ↗
• DeathMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 3 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 CASING DEVICE WAS USED TOGETHER WITH THE SMALL BATTERY DRIVE DEVICE, CHUCK DEVICE AND THE BATTERY 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 11797298 ↗
• MalfunctionMar 12, 2021Premature Separation; Premature Separation

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND REPAIR/PRE-TESTING, IT WAS OBSERVED THAT THE SMALL BATTERY DRIVE CASING DEVICE DISENGAGED UNEXPECTEDLY, THE CONTACT WAS DAMAGED AND THE DEVICE WOULD NOT SECURE/HOLD THE BATTERY DEVICE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK THE CONTACTS AND ATTACHED/LOCKING CHECK. 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 2020. 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 11475219 ↗
• MalfunctionJul 10, 2020Premature Separation; Premature Separation

  IT WAS REPORTED FROM (B)(6) THAT AFTER STERILIZATION. THE LID OF THE BATTERY CASING DEVICE WOULD SOMETIMES COME OFF. IT WAS REPORTED THAT AFTER THE DEVICE WAS STERILIZED FIVE TIMES THE LID OF THE DEVICE WAS STILL COMING OFF. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A DELAY TO A PLANNED PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. 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 2020. 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 10256909 ↗
• MalfunctionJun 2, 2020Premature Separation; Premature Separation

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SMALL BATTERY DRIVE DEVICE HAD UNINTENDED/UNEXPECTED DISENGAGEMENT AND FAILED PRE-TEST FOR CHECK THE CONTACTS, BATTERY CHECK, ATTACHED/LOCKING CHECK, FUNCTIONAL CHECK/CONTACTING AND LEAKAGE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNSPECIFIED MALFUNCTION. 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 2020. 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 10108605 ↗
• MalfunctionOct 16, 2019Premature Separation; Premature Separation

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SMALL BATTERY DRIVE CASING DEVICE HAD UNINTENDED/UNEXPECTED DISENGAGEMENT. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK EVEN WHEN THE BATTERY DEVICE WAS INSERTED. 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 2019. 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 9198041 ↗
• MalfunctionAug 23, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SMALL BATTERY DRIVE DEVICE TRIGGER DID NOT MOVE SMOOTHLY. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK WHILE BEING USED WITH A BATTERY CASING. 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 THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2019. 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 8925075 ↗
• MalfunctionAug 12, 2019Intermittent Energy Output; Intermittent Energy Output

  IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT EVERY ONCE AND A WHILE, THE USER HAD TO HIT THE BOTTOM OF THE BATTERY CASING DEVICE WITH THE PALM OF THEIR HAND IN ORDER TO MAKE THE SMALL BATTERY DRIVE DEVICE RUN. IT WAS FURTHER REPORTED THAT THE DEVICES WERE NOT BEING PAIRED ANYMORE. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE OF IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. 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 2019. 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 8885546 ↗
• MalfunctionJul 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SMALL BATTERY DRIVE CASING DEVICE HAD AN UNINTENDED/UNEXPECTED INTERACTION. IT WAS FURTHER DETERMINED THAT THE DEVICE WAS DISENGAGED. IT WAS NOTED IN THE SERVICE ORDER THAT THE POWER OF THE SMALL BATTERY DRIVE CASING DEVICE WAS GETTING WEAK. IT WAS FURTHER DETERMINED THAT THE SMALL BATTERY DRIVE DEVICE DID NOT WORK EVEN WHEN THE BATTERY DEVICE CHANGED. 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 2019. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8818199 ↗
• MalfunctionJun 20, 2019Unintended System Motion; Unintended System Motion

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SMALL BATTERY DRIVE CASING DEVICE HAD AN UNINTENDED/UNEXPECTED DISENGAGEMENT. IT WAS DETERMINED THAT THE DEVICE HAD A COSMETIC DAMAGE AND WAS WORN. IT WAS FURTHER OBSERVED THAT THE DEVICE HAD A CONTACT DAMAGE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNDETERMINED MALFUNCTION WHILE BEING USED TOGETHER WITH THE SMALL BATTERY DRIVE DEVICE. 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 AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8716635 ↗
• MalfunctionJan 9, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THIS IS EVENT 3 OF 3 OF THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SMALL BATTERY DRIVE DEVICE FAILED WHILE IN USE WITH TWO BATTERY CASING DEVICES. IT WAS UNKNOWN IF THERE WAS A DELAY TO THE SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SPARE DEVICE. 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 7175776 ↗
• MalfunctionJan 9, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THIS IS EVENT 2 OF 3 OF THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SMALL BATTERY DRIVE DEVICE FAILED WHILE IN USE WITH TWO BATTERY CASING DEVICES. IT WAS UNKNOWN IF THERE WAS A DELAY TO THE SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SPARE DEVICE. 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 7175766 ↗