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NA 532.010Recalls & reported problems

Synthes GmbH · SMALL BATTERY DRIVE · Class 1

Quick summary

This Synthes small battery drive has 144 FDA adverse event reports, with no deaths and no injuries. Many describe the trigger sticking so the drill keeps running, unexpected movement, noise, overheating and jamming. Most reports list no consequences for the patient. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
144
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 144 adverse event reports that list this exact device (DI 10886982240385), received between Oct 24, 2017 and Oct 28, 2024 — classified as 144 malfunctions.

The most frequently reported specific device problem is “Noise, Audible” (31 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Noise, Audible31
  • Unintended System Motion28
  • Fail-Safe Problem18
  • Mechanical Jam16
  • Overheating of Device10
  • Physical Resistance/Sticking10
  • Complete Loss of Power9
  • Intermittent Loss of Power9

Patient problems

  • No Consequences Or Impact To Patient80
  • No Known Impact Or Consequence To Patient31
  • No Clinical Signs, Symptoms or Conditions23
  • Not Applicable12

Recent adverse event reports

The 25 most recent of 144 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 28, 2024Unintended System Motion; Physical Resistance/Sticking; Unintended System Motion; Physical Resistance/Sticking

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SMALL BATTERY DRIVE DEVICE DRILL KEPT GOING (TRIGGER STICKING) EVEN WHEN YOU RELEASE YOUR FINGER FROM THE TRIGGER. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THE FACILITY IS A VETERINARY MEDICAL HOSPITAL, AND THEREFORE, THE DEVICE IS MOST LIKELY USED FOR VETERINARY PURPOSES ONLY. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20543398 ↗
  • MalfunctionJul 11, 2024Unintended System Motion; Appropriate Device Problem Term/Code Not Available; Unintended System Motion; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED FROM CANADA THAT THE DURING AN UNSPECIFIED PROCEDURE, IT WAS OBSERVED THAT THE SMALL BATTERY DRIVE DEVICE WAS NOT WORKING PROPERLY; THE DEVICE KEPT WORKING EVEN AFTER THE TRIGGER BUTTON WAS RELEASED. 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 19726409 ↗
  • MalfunctionSep 26, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    IT WAS REPORTED FROM CANADA THAT THE REVERSE BUTTON OF THE SMALL BATTERY DRIVE DEVICE WAS DISPLACED FROM ITS ORIGINAL POSITION. A PHOTOGRAPHIC IMAGE WAS RECEIVED FROM THE CUSTOMER. THE PHOTO WAS REVIEWED AND COMPARED TO A KNOWN GOOD UNIT. DURING THE IN-HOUSE REVIEW OF THE PHOTOGRAPHIC IMAGE, IT WAS OBSERVED THAT THE COMPLETE UPPER TRIGGER WAS MISSING FROM THE HANDPIECE AND THE DEVICE APPEARED TO BE WORN. IT WAS FOUND THAT THE DEVICE FAILED VISUAL INSPECTION. 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. 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17818749 ↗
  • MalfunctionNov 7, 2022Physical Resistance/Sticking; Complete Loss of Power; Physical Resistance/Sticking; Complete Loss of Power

    IT WAS REPORTED THAT THE SMALL BATTERY DRIVE DEVICE DID NOT FUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE TIP OF THE UPPER TRIGGER WAS BINDING WHICH CAUSED THE DEVICE TO FAIL CHECK TRIGGERS AND ELECTRIC CONTROL UNIT (ECU) TEST. 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 DATE OF EVENT WAS UNKNOWN. 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 15743602 ↗
  • MalfunctionOct 25, 2022Excessive Heating; Excessive Heating

    IT WAS REPORTED THAT DURING AN UNSPECIFIED VETERINARY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SMALL BATTERY DRIVE DEVICE BECAME HOT WHILE IN USE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THIS WAS A VETERINARY PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. 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 15665370 ↗
  • MalfunctionApr 14, 2022Output below Specifications; Physical Resistance/Sticking; Output below Specifications; Physical Resistance/Sticking

    IT WAS REPORTED FROM (B)(6) THAT THE SMALL BATTERY DRIVE DEVICE WAS NOT POWERFUL ENOUGH. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS OBSERVED THAT THE TRIGGER WAS STICKING, AND THE DEVICE MADE AN UNUSUAL NOISE. IT WAS FURTHER DETERMINED THAT THE DEVICE PASSED THE POWER AND VISUAL INSPECTION TEST. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION (DUE TO UNUSUAL NOISE), CHECK THE TRIGGERS AND ELECTRONIC CONTROL UNIT (ECU) FUNCTION, CHECK THE FUNCTION WITH EPD-CONSOLE AND LUBRICATE. 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. THE EXACT DATE OF THE EVENT WAS UNKNOWN. 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14112157 ↗
  • MalfunctionJan 14, 2022Output below Specifications; Excessive Heating; Output below Specifications; Excessive Heating

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SMALL BATTERY DRIVE DEVICE GUIDE WIRE GOT HOT AND WOULD NOT MOVE. ACCORDING TO THE REPORTER, THE DEVICE WAS MOVING SLOW, NOT AT FULL SPEED. IT WAS UNKNOWN IF THERE WERE DELAY IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN. 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 13257898 ↗
  • MalfunctionJan 7, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

    IT WAS REPORTED THAT THE SMALL BATTERY DRIVE DEVICE BOTTOM BUTTON WAS STICKING (STICKY TRIGGER) IN A VETERINARY FACILITY. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. THERE WAS NO 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 DATE OF EVENT WAS UNKNOWN. 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 13191659 ↗
  • MalfunctionDec 7, 2021Intermittent Loss of Power; Intermittent Loss of Power

    IT WAS REPORTED FROM (B)(6) THAT THE SMALL BATTERY DRIVE DEVICE WORKED INTERMITTENTLY. 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 12953333 ↗
  • MalfunctionNov 2, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

    IT WAS REPORTED THAT DURING TESTING IT WAS OBSERVED THAT THE ON/OFF BUTTONS OF THE SMALL BATTERY DRIVE DEVICE WAS STICKING. 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 12737199 ↗
  • MalfunctionAug 18, 2021Output below Specifications; Excessive Heating; Output below Specifications; Excessive Heating

    IT WAS REPORTED THAT THE SMALL BATTERY DRIVE DEVICE RAN SLOW AND BECAME VERY HOT. 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 WAS NO HUMAN PATIENT INVOLVEMENT AS THIS DEVICE IS FOR VETERINARY USE ONLY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. 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 12336200 ↗
  • MalfunctionAug 6, 2021Noise, Audible; Noise, Audible

    IT WAS REPORTED FROM (B)(6) THAT THE SMALL BATTERY DRIVE DEVICE WAS NOISY WHEN NOT IN OPERATION. 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 12288371 ↗
  • MalfunctionJun 1, 2021Complete Loss of Power; Complete Loss of Power

    IT WAS REPORTED FROM CANADA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE SMALL BATTERY DRIVE DEVICE STOPPED WORKING. IT WAS REPORTED THAT THERE WAS NO DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS REPORTED THAT 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 NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED ON THE 26TH DAY OF AN UNKNOWN MONTH IN 2021. 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 11914455 ↗
  • MalfunctionApr 8, 2021Output below Specifications; Noise, Audible; Output below Specifications; Noise, Audible

    IT WAS REPORTED THAT DURING AN UNSPECIFIED VETERINARY SURGICAL PROCEDURE IT WAS OBSERVED THAT THE SMALL BATTERY DRIVE DEVICE WAS MAKING LOUD NOISES AND WAS NOT PERFORMING PROPERLY. IT WAS REPORTED THAT THE DEVICE DID NOT HAVE ENOUGH POWER AND WAS NOT ABLE TO DRIVE THROUGH THE BONE. IT WAS REPORTED THAT THERE WAS NO DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS REPORTED THAT AN UNSPECIFIED SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THIS WAS A VETERINARY PROCEDURE. 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 ¿ABOUT A MONTH AGO¿. 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 11637756 ↗
  • MalfunctionMar 8, 2021Noise, Audible; Noise, Audible

    IT WAS REPORTED FROM (B)(6) THAT THE SMALL BATTERY DRIVE DEVICE WAS MAKING A SQUEALING NOISE. 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. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2021. 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 11438793 ↗
  • MalfunctionMar 5, 2021Complete Loss of Power; Complete Loss of Power

    IT WAS REPORTED FROM (B)(6) THAT THE SMALL BATTERY DRIVE DEVICE STOPPED RUNNING ON ITS OWN. 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 DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2021. 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 11422917 ↗
  • MalfunctionJan 8, 2021Noise, Audible; Noise, Audible

    IT WAS REPORTED FROM (B)(6) THAT THE SMALL BATTERY DRIVE DEVICE WAS NOT WORKING PROPERLY, AND THE DRILL WAS MAKING A SQUEALING NOISE. 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. 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 11140332 ↗
  • MalfunctionJan 5, 2021Intermittent Loss of Power; Intermittent Loss of Power

    IT WAS REPORTED THAT DURING TESTING PRIOR TO A CASE, IT WAS OBSERVED THAT THE SMALL BATTERY DRIVE DEVICE SOMETIMES WORKS AND SOMETIMES DOESN'T. 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. 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 11121157 ↗
  • MalfunctionDec 30, 2020Intermittent Loss of Power; Intermittent Loss of Power

    IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SMALL BATTERY DRIVE DEVICE HAD INTERMITTENT ELECTRICAL FUNCTION. 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. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED 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 11094877 ↗
  • MalfunctionDec 8, 2020Complete Loss of Power; Complete Loss of Power

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SMALL BATTERY DRIVE DEVICE WAS EITHER SMOKING OR STOPPED WORKING DURING USE. THE REPORTER WAS UNABLE TO CLARIFY WHICH EVENT OCCURRED. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. IT WAS UNKNOWN IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN NOVEMBER 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 10968689 ↗
  • MalfunctionDec 8, 2020Complete Loss of Power; Complete Loss of Power

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SMALL BATTERY DRIVE DEVICE WAS EITHER SMOKING OR WOULD NOT RUN. THE REPORTER WAS UNSURE ABOUT WHICH ONE OCCURRED. THERE WERE NO REPORTS OF SURGICAL DELAY. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN (B)(6) 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 10968664 ↗
  • MalfunctionDec 5, 2020Complete Loss of Power; Complete Loss of Power

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SMALL BATTERY DRIVE DEVICE STOPPED WORKING OR STARTED SMOKING. IT WAS REPORTED THAT THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. IT WAS NOT REPORTED WHETHER A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN, HOWEVER IT WAS REPORTED THAT IT OCCURRED IN (B)(6) 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 10951225 ↗
  • MalfunctionNov 17, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

    IT WAS REPORTED THAT THE LOWER TRIGGER BUTTON OF THE SMALL BATTERY DRIVE DEVICE WAS STICKING. 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 HUMAN PATIENT INVOLVEMENT AS THIS DEVICE IS INTENDED FOR VETERINARY USE ONLY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED. 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 10856112 ↗
  • MalfunctionNov 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TRIGGER TO HOLD THE ATTACHMENT DEVICE FELL OFF FROM THE HANDPIECE OF THE SMALL BATTERY DRIVE DEVICE. 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 REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN, BUT WAS NOTED 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; No Consequences Or Impact To Patient

    MAUDE report 10843991 ↗
  • MalfunctionNov 16, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

    IT WAS REPORTED THAT THE BUTTONS ON THE SMALL BATTERY DRIVE DEVICE WERE STICKING AND ONE OF THE RELEASE LEVERS WERE LOOSE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THIS DEVICE IS INTENDED FOR VETERINARY USE ONLY. 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 DATE OF EVENT WAS UNKNOWN. 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 10842623 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.