KINCISE™ 1000-00-101Recalls & reported problems

Summary

The FDA's MAUDE database contains 242 adverse event reports that list this exact device (DI 00845384018520), received between Apr 6, 2021 and Sep 29, 2026 — classified as 1 injury, 241 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (87 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 242 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937311 ↗
• MalfunctionJul 28, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50053918 ↗
• MalfunctionFeb 19, 2026Unintended System Motion; Physical Resistance/Sticking; Intermittent Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE IMPACTOR DEVICE WAS HAD A STICKY TRIGGER AND UNINTENDED ACTIVATION. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS MISFIRING DURING SURGERY. 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 24393071 ↗
• MalfunctionJan 20, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE ADAPTOR DEVICE BROKE INTO MULTIPLE PIECES. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED 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 24114785 ↗
• MalfunctionJan 6, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PRE-SURGERY, IT WAS DISCOVERED THAT THE BOTTOM PIECE OF THE IMPACTOR DEVICE CAME OFF THE DEVICE AS A WHOLE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN 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 23973422 ↗
• MalfunctionDec 17, 2025Detachment of Device or Device Component; Noise, Audible; Complete Loss of Power; Detachment of Device or Device Component; Noise, Audible; Complete Loss of Power

  IT WAS REPORTED THAT THE CASE ON THE SURGICAL IMPACTOR DEVICE SEPARATED. IT WAS FURTHER REPORTED THAT THE DEVICE WOULD NOT FILE AND HAD A FAINT CLICKING SOUND. THE ISSUE WAS OBSERVED DURING TESTING. 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 23831058 ↗
• MalfunctionNov 3, 2025Device-Device Incompatibility; Physical Resistance/Sticking; Device-Device Incompatibility; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE IMPACTOR DEVICE WAS IMPLANTING THE CUP THE KINCISE 2 IMPACTOR BUTTON ON THE TOP OF THE GUN (REVERSE) GOT STUCK AND CONTINUE TO IMPACT INSIDE OF THE CAR PATIENT AND CAUSED THE CUP TO NOT BE ABLE TO STICK ANYMORE AND WE HAD TO REAM UP AND PUT IN A 54 CUP INSTEAD, WE CHECKED THE K2 GUN LATER AND THE BUTTON WAS NOT STUCK ANYMORE. THERE WAS NO DELAY IN SURGERY. 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 23457915 ↗
• MalfunctionNov 3, 2025Material Fragmentation; Material Fragmentation

  REPORT 1 OF 2 FOR (B)(4) IT WAS REPORTED THAT THE INTERNAL LATCH MECHANISM WAS SNAPPING OFF 2X FEMORAL BROACH ADAPTER DEVICES. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23448744 ↗
• MalfunctionNov 3, 2025Material Fragmentation; Material Fragmentation

  REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT THE INTERNAL LATCH MECHANISM WAS SNAPPING OFF 2X FEMORAL BROACH ADAPTER DEVICES. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23448736 ↗
• MalfunctionSep 15, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING DEVICE TESTING IT WAS FOUND THAT THE IMPACTOR DEVICE WOULD FIRE ON ITS OWN. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 23053160 ↗
• MalfunctionSep 15, 2025Noise, Audible; Physical Resistance/Sticking; Complete Loss of Power; Noise, Audible; Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED THAT THE IMPACTOR DEVICE HAD A MECHANICAL NOISE, BUT NO MOVEMENT AND THE TRIGGER WAS STUCK. IT WAS NOT REPORTED THAT THIS ISSUE WAS DISCOVERED PRE-SURGERY. 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 23052978 ↗
• MalfunctionSep 9, 2025Electrical /Electronic Property Problem; Complete Loss of Power; Electrical /Electronic Property Problem; Complete Loss of Power

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE IMPACTOR DEVICE WOULD NOT FIRE. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE DEVICE WOULD NOT IMPACT BUT THE MOTOR WAS RUNNING. THE DEVICE WAS OPENED, AND IT WAS FOUND THAT THE MOTOR MAGNETS SEPARATED FROM THE DRIVE SHAFT. 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 23004072 ↗
• MalfunctionAug 6, 2025Device Slipped; Detachment of Device or Device Component; Device Slipped; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT WHILE BROACHING THE FEMUR USING THE IMPACTOR DEVICE IT WAS OBSERVED THAT THE DEVICE WAS DAMAGED AND THE FOREHAND GRIP BECAME LOOSE AND BEGAN ROTATING. IT WAS REPORTED THAT THE WHOLE FOREHAND GRIP AND COLLAR COVERING THE ANVIL BECOME SEPARATED. IT WAS REPORTED THAT THERE WAS A SMALL DELAY TO THE SURGICAL PROCEDURE HOWEVER, THE DURATION OF THE DELAY WAS NOT SPECIFIED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22724869 ↗
• MalfunctionJul 24, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE IMPACTOR DEVICE TIP BROKE WHEN IMPACTING THE HEAD OF THE IMPLANT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR WHETHER A SPARE DEVICE WAS AVAILABLE FOR USE. 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 22587524 ↗
• MalfunctionJul 23, 2025Physical Resistance/Sticking; Intermittent Loss of Power; Physical Resistance/Sticking; Intermittent Loss of Power

  IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE KINCISE AUTOMATED SURGICAL IMPACTOR DEVICE TRIGGER WAS STICKING CREATING INCONSISTENT FIRING AND IMPACTION. THE 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 22579536 ↗
• MalfunctionJul 23, 2025Unintended System Motion; Appropriate Device Problem Term/Code Not Available; Unintended System Motion; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE TRIGGER ON THE IMPACTOR DEVICE WAS NOT WORKING PROPERLY AND SOMETIMES AUTO-FIRING WITHOUT BEING PRESSED. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED 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 22576744 ↗
• MalfunctionJul 18, 2025Unintended System Motion; Physical Resistance/Sticking; Unintended System Motion; Physical Resistance/Sticking

  IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE KINCISE AUTOMATED SURGICAL IMPACTOR DEVICE WAS STUCK IN FULL AUTO MODE AND THE ONLY WAY TO SHUT IF OFF WAS TO REMOVE THE BATTERY DEVICE. DURING FURTHER FOLLOW UP WITH THE REPORTER IT WAS STATED THAT THE DEVICE WOULD KEEP GETTING STUCK. THE EVENT DID NOT OCCUR DURING SURGERY. 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 22541845 ↗
• MalfunctionJul 9, 2025Unintended System Motion; Noise, Audible; Physical Resistance/Sticking; Complete Loss of Power; Unintended System Motion; Noise, Audible; Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT THE IMPACTOR DEVICE KEPT MAKING A RUNNING NOISE WITH NO IMPACTION, AND RANDOMLY KEPT FIRING AND COULD NOT BE STOPPED. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 22461453 ↗
• MalfunctionJul 9, 2025Physical Resistance/Sticking; Complete Loss of Power; Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED THAT DURING PRE-SURGERY, IT WAS DISCOVERED THAT THE TRIGGER OF THE IMPACTOR DEVICE STAYED IN THE STEP POSITION AND WOULD NOT FIRE ANY LONGER. THERE WAS A DELAY TO THE SURGICAL PROCEDURE. HOWEVER, THE DURATION OF THE DELAY WAS NOT SPECIFIED. IT WAS NOT REPORTED 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 22461200 ↗
• MalfunctionJun 30, 2025Electrical /Electronic Property Problem; Unintended System Motion; Electrical /Electronic Property Problem; Unintended System Motion

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE IMPACTOR DEVICE DID NOT STOP FIRING AFTER PULLING THE TRIGGER. IT WAS NOT REPORTED THAT THERE WERE NO DELAYS IN THE PROCEDURE. IT WAS NOT REPORTED WHETHER A SPARE DEVICE WAS AVAILABLE FOR USE. 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 22357217 ↗
• MalfunctionJun 26, 2025Physical Resistance/Sticking; Complete Loss of Power; Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED THAT THE IMPACTOR DEVICE WOULD NOT IMPACT. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD A STICKY TRIGGER. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 22335342 ↗
• MalfunctionJun 25, 2025Unintended System Motion; Complete Loss of Power; Intermittent Energy Output; Unintended System Motion; Complete Loss of Power; Intermittent Energy Output

  IT WAS REPORTED THAT THE IMPACTOR DEVICE WOULD NOT FIRE. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE TRIGGER WAS DIFFICULT TO DEPRESS/PRESS RESULTING IN UNINTENDED OPERATION CONSISTENT WITH LACK OF LURBRICANT - IMPROPER MAINTENANCE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR INTERMITTENT TEST ASSESSMENT. 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 22330184 ↗
• MalfunctionJun 20, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE KINCISE IMPACTOR DEVICE TRIGGER WAS STICKING. 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 22301450 ↗
• MalfunctionJun 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT THE TOP BUTTON ON THE GUN OF THE IMPACTOR DEVICE SHOT OFF DURING A TEST FIRE. IT WAS REPORTED THAT THE PATIENT WAS NOT IN THE SURGICAL ROOM WHEN THE EVENT OCCURRED. 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 22161469 ↗
• MalfunctionJun 6, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING PRE-SURGERY, THE IMPACTOR DEVICE TRIGGER WAS STUCK AND NOT SPRINGING BACK. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 22159946 ↗