NA 05.001.080Recalls & reported problems

Summary

The FDA's MAUDE database contains 432 adverse event reports that list this exact device (DI 10886982128997), received between Nov 29, 2017 and Jun 29, 2026 — classified as 1 injury, 431 malfunctions.

The most frequently reported specific device problem is “Output below Specifications” (288 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 25 most recent of 432 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2026Break; Unintended System Motion

  IT WAS REPORTED THAT THE AIR PEN DRIVE DEVICE DID NOT STOP RUNNING; THE CONTROL UNIT WAS DAMAGED. 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. 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 25652936 ↗
• MalfunctionApr 29, 2026Complete Loss of Power

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE AIR PEN DRIVE DEVICE SEIZED WHEN THE PIN OR DRILL BIT WAS FITTED INTO THEIR RESPECTIVE COUPLINGS - THEY COULD NOT ROTATE AND STAYED JAMMED. IT HAD NO EFFECT ON THE PATIENT. THERE WAS A SLIGHT DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034232 ↗
• MalfunctionApr 10, 2026Fail-Safe Did Not Operate

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE AIR PEN DRIVE DEVICE RUN IN THE LOCKED POSITION. 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 24839689 ↗
• MalfunctionApr 7, 2026Unintended System Motion; Intermittent Loss of Power

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY THE AIR PEN DRIVE DEVICE INTERMITTENTLY FAILED TO OPERATE AND SOMETIMES ACTIVATED WITHOUT THE TRIGGER BEING PRESSED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE 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 24799678 ↗
• MalfunctionMar 26, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING SURGERY, IT WAS OBSERVED THAT AFTER WORKING ON THE BONE, THE AIR POWERED HANDPIECE DEVICE REMAINED ACTIVE WHETHER IT WAS THE DRILL BIT, SAW, OR KIRSCHNER WIRE MOUNTED IN THE ADAPTER. ACCORDING TO THE REPORTER, THE SPECIALIST EXPRESSED CONCERN, AS THIS CAN LEAD TO INCONSISTENCIES AND POSE A RISK TO THE SURGICAL TEAM. IT CAUSED PROBLEMS BECAUSE IF A THREADED PIN WAS INSERTED, IT WOULD RETRACT WHILE THE HANDPIECE WAS ACTIVE. IT WAS REPORTED THAT THE DEVICE WAS BEING USED WITH A HANDSWITCH DEVICE AND A 3M HOSE. IT WAS FURTHER REPORTED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY. THE INJURY DOES NOT CAUSE MAJOR INVOLVEMENT TO THE PATIENT; IT WAS ONLY SOFT TISSUES THAT BECAME ENTANGLED IN THE DRILL BIT. THERE WERE NO REPORTS OF MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699668 ↗
• MalfunctionMar 23, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE HANDPIECE DEVICE REMAINED ACTIVATED EVEN AFTER THE TRIGGER WAS RELEASED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664654 ↗
• MalfunctionMar 20, 2026Unintended System Motion

  THIS IS REPORT 1 OF 2 OF THE SAME EVENT: IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE AIR PEN DRIVE DEVICE TOOK A LONG TIME TO STOP AFTER ACTIVATION; THE DRILL BITS WERE UNEDGED (DULL), WHICH CAUSED THEM TO OVERHEAT AND BREAK, LEAVING FRAGMENTS RETAINED INSIDE THE PATIENT. THE DEVICES HAD BEEN USED WITH AN UNKNOWN ATTACHMENT. IT WAS REPORTED THAT THE SURGERY WAS DELAYED FOR AN UNSPECIFIED DURATION AND THAT A SPARE DEVICE WAS USED TO COMPLETE THE 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 24650238 ↗
• MalfunctionFeb 26, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE IT WAS OBSERVED THAT THE AIR PEN DRIVE DEVICE ENGINE WAS STILL RUNNING EVEN WHEN THE TRIGGER WAS NOT BEING PRESSED OR OPERATED, WHICH CAUSED DISCOMFORT IN THE SPECIALIST SINCE. THE MOTOR WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456325 ↗
• MalfunctionDec 30, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE AIR PEN DRIVE DEVICE CONTINUED TO RUN DESPITE THE REQUEST TO STOP. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. 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 23922924 ↗
• MalfunctionDec 5, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE AIR PEN DRIVE (APD) DEVICE HAD CORROSION/RUSTING/PITTING, THE DEVICE WOULD RUN IN THE LOCKED POSITION, HAD INSUFFICIENT/LOW POWER, AND AN AIR LEAK. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK HANDPIECE IN ¿LOCK¿ MODE, CHECK GENERAL FUNCTION WITH APD HAND SWITCH, CHECK POWER WITH POWER TEST BENCH, CHECK SPEED WITH TACHOMETER, CHECK FOR EXTERNAL LEAK TIGHTNESS, AND CHECK FOR INTERNAL LEAK TIGHTNESS. 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 2025. 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 23727904 ↗
• MalfunctionDec 4, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE AIR PEN DRIVE DEVICE RAN IN LOCKED POSITION. 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 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720739 ↗
• MalfunctionDec 3, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE AIR PEN DRIVE (APD) DEVICE HAD INSUFFICIENT POWER CAUSING THE INSTRUMENT TO RUN SLOW, AND/OR WITH LOWER ENERGY, HAD AN AIR, AND THE DEVICE WOULD RUN IN THE LOCKED POSITION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK HANDPIECE IN ¿LOCK¿ MODE, CHECK GENERAL FUNCTION WITH APD HAND SWITCH, CHECK POWER WITH POWER TEST BENCH, CHECK SPEED WITH TACHOMETER, CHECK FOR INTERNAL LEAK TIGHTNESS, CHECK FOR EXTERNAL LEAK TIGHTNESS. 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 2025. 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 23708661 ↗
• MalfunctionSep 15, 2025Fail-Safe Problem; Fail-Safe Problem

  IT WAS REPORTED THAT THE PEN DRIVE DEVICE WAS RETURNED FOR MAINTENANCE. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE RAN IN THE LOCKED POSITION. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23050603 ↗
• MalfunctionSep 11, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION; IT WAS DETERMINED THAT THE AIR PEN DRIVE DEVICE RAN IN A LOCKED POSITION AND HOUSING WAS CRACKED. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23024602 ↗
• MalfunctionSep 8, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE HANDPIECE DEVICE RAN IN THE LOCKED POSITION. IT WAS FURTHER DETERMINED THAT THE DEVICE HAD INSUFFICIENT POWER CAUSING THE INSTRUMENT TO RUN SLOW, AND/OR WITH LOWER ENERGY. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22994177 ↗
• MalfunctionAug 12, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS DISCOVERED THAT THE AIR PEN DRIVE DEVICE RAN IN LOCKED POSITION. IT WAS FURTHER DETERMINED THAT THE DEVICE HAD INSUFFICIENT/LOW POWER, COMPONENT DAMAGE, FLUID INGRESS, AN AIR LEAK AND THE ETCHING ON THE LABELING WAS ILLEGIBLE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, MARKINGS, CHECK HANDPIECE IN ¿LOCK¿ MODE, CHECK GENERAL FUNCTION WITH APD HAND, CHECK POWER WITH POWER TEST BENCH, CHECK SPEED WITH TACHOMETER, CHECK FOR INTERNAL LEAK TIGHTNESS AND CHECK FOR EXTERNAL LEAK TIGHTNESS. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22785852 ↗
• MalfunctionJul 29, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE AIR PEN DRIVE DEVICE RAN IN A LOCKED POSITION, LEAKED AIR, HAD INSUFFICIENT/LOW POWER, COMPONENT DAMAGE AND FLUID INGRESS. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK HANDPIECE IN ¿LOCK¿ MODE, CHECK GENERAL FUNCTION WITH APD HAND SWITCH, CHECK POWER WITH POWER TEST BENCH, CHECK SPEED WITH TACHOMETER THE VALUE OF TACHOMETER, CHECK FOR INTERNAL LEAK TIGHTNESS AND CHECK FOR EXTERNAL LEAK TIGHTNESS. IT WAS NOTED THAT THE DEVICE HAD INSUFFICIENT POWER CAUSING THE DEVICE TO RUN SLOW AND/OR WITH LOWER ENERGY. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22641161 ↗
• MalfunctionJul 24, 2025Fail-Safe Problem; Fail-Safe Problem

  IT WAS REPORTED THAT THE PEN DRIVE DEVICE WAS FOUND TO HAVE GRADUAL DETERIORATION OF MATERIALS IN THE INTERNAL AND EXTERNAL COMPONENTS. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE RAN IN THE LOCKED POSITION. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22589076 ↗
• MalfunctionJun 30, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE AIR PEN DRIVE DEVICE, AT THE TIME OF OPENING THE NITROGEN KEY, THE ENGINE STARTED TO OPERATE DIRECTLY AND DID NOT STOP. IT WAS REPORTED THAT THE SPECIALIST USED THE DEVICE IN THIS CONDITION, AND AFTER A WHILE THE ENGINE STOPPED AND STARTED TO WORK PROPERLY. 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 22358552 ↗
• MalfunctionJun 25, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT DURING SERVICE AND REPAIR/PRE-TESTING, IT WAS OBSERVED THAT THE AIR PEN DRIVE DEVICE HAD INSUFFICIENT/LOW POWER, COMPONENT DAMAGE, RAN IN THE LOCKED POSITION, FLUID INGRESS AND WAS LEAKING AIR. THE DEVICE ALSO FAILED PRETESTS FOR GENERAL CONDITION, CHECK HANDPIECE IN ¿LOCK¿ MODE, CHECK GENERAL FUNCTION WITH APD HAND SWITCH, CHECK POWER WITH POWER TEST BENCH, CHECK SPEED WITH TACHOMETER, CHECK FOR INTERNAL LEAK TIGHTNESS AND CHECK FOR EXTERNAL LEAK TIGHTNESS. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 22328794 ↗
• MalfunctionJun 24, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT THE AIR PEN DRIVE DEVICE (APD) HAD GRADUAL DETERIORATION OF MATERIALS IN THE INTERNAL AND EXTERNAL COMPONENTS. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE DEVICE HAD COMPONENT DAMAGE, AND AIR LEAK, FLUID INGRESS, INSUFFICIENT/LOW POWER, AND THE DEVICE WOULD RUN IN THE LOCKED POSITION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK HANDPIECE IN ¿LOCK¿ MODE, CHECK GENERAL FUNCTION WITH APD HAND SWITCH, CHECK POWER WITH POWER TEST BENCH, CHECK SPEED WITH TACHOMETER, CHECK FOR INTERNAL LEAK TIGHTNESS, AND CHECK FOR EXTERNAL LEAK TIGHTNESS. 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 2025. 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 22319242 ↗
• MalfunctionJun 19, 2025Break; Appropriate Device Problem Term/Code Not Available; Premature Separation; Break; Appropriate Device Problem Term/Code Not Available; Premature Separation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE WHILE USING THE AIR PEN DRIVE DEVICE WHEN PERFORMING THE ADAPTATION BETWEEN THE HANDPIECE DEVICE OF THE AIR PEN ENGINE AND THE CONNECTION HOSE THAT COMES STERILE, IT WAS EVIDENT THAT THERE WAS A RUPTURE SINCE THESE TWO ARE DISCONNECTED DURING THE USE OF THE ENGINE. IT TRIED TO LOWER THE PRESSURE OF THE ENGINE BUT IT DID NOT REMAIN CONNECTED IN THE SAME WAY. WHEN BOTH PIECES WERE RE-JOINED, THESE WERE NOT MAINTAINED. A SCALPEL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF DELAY TO THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293602 ↗
• MalfunctionMay 27, 2025Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED THAT THE AIR PEN DRIVE DEVICE STOPPED WORKING DURING USE. 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. 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 22089728 ↗
• MalfunctionMay 16, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, AFTER ASSEMBLING AND CONNECTING THE AIR PEN DRIVE DEVICE, AND OPENING THE GAUGE, IT WAS OBSERVED THAT THE DEVICE BEGINS TO OPERATE IMMEDIATELY WITHOUT ALLOWING IT TO STOP SINCE, APPARENTLY IT WAS DIRECT. IT WAS REPORTED THAT ALL PARTS WERE THEN SEPARATED AND ASSEMBLED AGAIN TO RULE OUT A FAILURE IN THE CONNECTION, BUT THE OPERATION OF THIS ENGINE WAS NOT SUCCESSFUL PRESENTING THE SAME FAILURE, AS IF IT WERE DIRECT OPERATION. IT WAS REPORTED THAT A SPARE DEVICE WAS AVAILABLE FOR USE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY. 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 22034415 ↗
• MalfunctionMay 5, 2025Break; Unintended System Motion; Mechanical Jam; Break; Unintended System Motion; Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE LOCK ON THE AIR PEN DRIVE DEVICE WAS NOT BLOCKING AND WHEN SWITCHING FROM FUNCTION IT STAYS ATTACHED AND LOCKS THE ENGINE IN OPERATION DIRECTLY. IT WAS REPORTED THAT THE SITUATION WAS RESOLVED BY MANAGING TO PASS THE BLOCKADE IN DIFFERENT FUNCTIONS, THUS ACHIEVING THAT IT WILL REMAIN IN COMMAND OF THE HAND. IT WAS REPORTED THAT THERE WAS NO DELAY IN THE PROCEDURE DUE TO THE EVENT. 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 21962645 ↗