KINCISE 200002102Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07612334268693), received between Oct 20, 2025 and Sep 17, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (12 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Material Fragmentation; Device-Device Incompatibility

  It was reported that the KINCISE device snapped and no longer locked to hold broaches. It was not reported if the device was used in 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 50803543 ↗
• MalfunctionSep 17, 2026Component Missing; Detachment of Device or Device Component

  It was reported that during in-house engineering evaluation, it was observed that the broach adapter device had missing components. It was noted by the reporter that during an unknown surgery the side button on the device came apart from the handle. 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 50803281 ↗
• MalfunctionSep 4, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50615776 ↗
• MalfunctionAug 12, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50221322 ↗
• MalfunctionAug 4, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50134311 ↗
• MalfunctionJul 29, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50074336 ↗
• MalfunctionApr 13, 2026Material Fragmentation; Device-Device Incompatibility

  IT WAS REPORTED THAT THE FEMORAL BROACH ADPT - STRAIGHT DEVICE SPRING MECHANISM LOST LATCH TO CLOSE THE BROACH IN PLACE DID NOT WORK. 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 24866324 ↗
• MalfunctionMar 23, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE BROACH ADAPTOR DEVICE, WHEN USED WITH AN UNKNOWN BATTERY HANDPIECE HAD LOW POWER AND NOT ENOUGH FORCE, AND METAL WAS CHIPPING AWAY AROUND THE HOLE. IT WAS REPORTED THAT THERE WAS AN UNSPECIFIED 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 24662399 ↗
• MalfunctionJan 20, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE BROACH ADAPTER DEVICE BROKE WHILE BROACHING WITH A KINCISE DEVICE. ALL PIECES WERE REMOVED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. 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 24114657 ↗
• MalfunctionDec 15, 2025Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE FEMORAL BROACH ADPT - STRAIGHT DEVICE BROKE INTO TWO PIECES. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE FELL APART AND WOULD NOT HOLD/RETAIN DURING ANTERIOR HIP SURGERY. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAY TO 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 23811667 ↗
• MalfunctionNov 5, 2025Material Fragmentation; Device Slipped; Material Fragmentation; Device Slipped

  IT WAS REPORTED THAT DURING TESTING, IT WAS OBSERVED THAT THE FEMORAL BROACH ADAPTER DEVICE LEVER WAS BROKEN. DURING FURTHER FOLLOW UP WITH THE REPORTER, IT WAS STATED THAT THE SPRING WAS BROKEN, LEVER STILL ATTACHED. THE LOCKING MECHANISM APPEARED TO BE LOOSE AND WAS NOT LOCKING. 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 23476268 ↗
• MalfunctionOct 30, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT FEMORAL BROACH ADPT - STRAIGHT BROKE. IT WAS FURTHER REPORTED THAT THE PIECE THAT IS HANGING OFF BROACH ADAPTER IS PART OF INTERNAL LOCKING MECHANISM, IT BREAKS /FALLS APART AND RELEASES THE BROACH DEVICE. 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 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 23426513 ↗
• MalfunctionOct 28, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE FEMORAL BROACH ADAPTER DEVICE BROKE IN THE FIELD. THE PIECE THAT WAS HANGING OFF BROACH ADAPTER WAS PART OF THE INTERNAL LOCKING MECHANISM - IT BREAKS / FALLS APART AND RELEASES THE BROACH. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. 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 23401602 ↗
• MalfunctionOct 20, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE FEMORAL BROACH ADAPTER DEVICE BROKE IN THE FIELD. THE PIECE THAT WAS HANGING OFF BROACH ADAPTER WAS PART OF THE INTERNAL LOCKING MECHANISM - IT BREAKS / FALLS APART AND RELEASES THE BROACH. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. 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 23335861 ↗