KINCISE™ 1010-01-102Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00845384018568), received between Oct 12, 2020 and Apr 13, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT THE BROACH DEVICES WERE GETTING STUCK ON THE ADAPTER. 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 24864364 ↗
• MalfunctionDec 10, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT POST SURGERY, IT WAS OBSERVED THAT THE ANTERIOR BROACH ADAPTER DEVICE WAS CHIPPED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771200 ↗
• MalfunctionNov 1, 2024Device-Device Incompatibility; Difficult or Delayed Separation; Device-Device Incompatibility; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE ANTERIOR BROACH ADAPTER DEVICE WAS VERY DIFFICULT TO OPEN AND CLOSE WHILE ATTACHED TO THE BROACH. THE DEVICE REMAINED IN THE CLOSED POSITION WITH THE BROACH STUCK ON IT. 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 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 20586942 ↗
• MalfunctionApr 10, 2024Material Fragmentation; Material Fragmentation

  THIS IS REPORT 2 OF 3 OF THE SAME EVENT: IT WAS REPORTED FROM AUSTRALIA THAT DURING A LOAN KIT INSPECTION BY THE LOAN KIT TECHNICIAN, IT WAS OBSERVED THAT THE FEM HEAD IMPACTOR DEVICE, THE BROACH ADAPTER DEVICE AND THE SHELL/LINER IMPACTOR DEVICE WERE CHIPPED. THE EVENT WAS NOT RELATED TO SURGERY. 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19080552 ↗
• MalfunctionApr 3, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE KINSISE ADAPTER DEVICE GOT STUCK ON THE BROACH DEVICE AND COULD NOT BE REMOVED. 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. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19032860 ↗
• MalfunctionNov 29, 2022Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  THIS IS REPORT 3 OF 3 OF THE SAME EVENT: IT WAS REPORTED FROM UNITED KINGDOM THAT DURING A DEVICE DEMONSTRATION, IT WAS OBSERVED THAT THE BROACH ADAPTER DEVICES WERE STIFF, AND ANOTHER INSTRUMENT HAD TO BE USED TO SEPARATE THE BROACHES FROM THE ADAPTERS ONCE THEY WERE LOCKED IN. THE EVENT WAS NOT RELATED TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. 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 15879735 ↗
• MalfunctionNov 29, 2022Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  THIS IS REPORT 2 OF 3 OF THE SAME EVENT: IT WAS REPORTED FROM UNITED KINGDOM THAT DURING A DEVICE DEMONSTRATION, IT WAS OBSERVED THAT THE BROACH ADAPTER DEVICES WERE STIFF, AND ANOTHER INSTRUMENT HAD TO BE USED TO SEPARATE THE BROACHES FROM THE ADAPTERS ONCE THEY WERE LOCKED IN. THE EVENT WAS NOT RELATED TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. 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 15879623 ↗
• MalfunctionJun 24, 2022Device-Device Incompatibility; Difficult or Delayed Separation; Device-Device Incompatibility; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT IT WAS DIFFICULT FOR THE CORAIL BROACH DEVICE TO ATTACH TO THE KINCISE BROACH ADAPTER DEVICE AND THE BROACH HANDLE DEVICE. IT WAS FURTHER REPORTED THAT THE CORAIL BROACH GOT STUCK ON THE BROACH ADAPTER. IT WAS REPORTED THAT THERE WAS A FIFTEEN-MINUTE DELAY TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF 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. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14800453 ↗
• InjuryJun 7, 2021Device-Device Incompatibility; Device-Device Incompatibility

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING A TOTAL HIP ARTHROPLASTY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ADAPTOR DEVICE COULD NOT BE REMOVED FROM THE IMPACTOR DEVICE. ACCORDING TO THE REPORTER, THE IMPACTION WAS BEING PERFORMED FROM SIZE 8 BROACH BY ATTACHING THE BROACH ADAPTER TO THE SURGICAL IMPACTOR DURING BROACHING. AFTER REACHING THE SIZE 10 BROACH, THE SURGICAL IMPACTOR ADAPTER DEVICE COULD NOT BE REMOVED WHEN THE SURGEON TRIED TO REMOVE IT FROM THE BROACH. IT WAS NOTED THAT THERE WERE NO PROBLEMS FROM SIZE 8 TO 9 BROACHES, HOWEVER FROM SIZE 10, THE BROACH COULD NOT BE ATTACHED. DUE TO THIS, THE LEVER OF THE BROACH WAS OPENED AND SLIGHTLY PULLED, AND IMPACT WAS APPLIED ONCE WITH SURGICAL IMPACTOR ADAPTER AND THE DEVICE COULD THEN BE REMOVED. AFTER THAT, THE SURGEON TRIED TO ATTACH THE SURGICAL IMPACTOR ADAPTER DEVICE TO THE BROACH AGAIN, BUT THE NECK OF THE BROACH DID NOT GO INTO THE BROACH ADAPTER AND COULD NOT BE ATTACHED. THEREFORE, THE SURGEON REPLACED IT WITH AN ANTERIOR BROACH HANDLE AND MANUALLY REMOVED THE SIZE 10 BROACH. SIZE 11 BROACHES WERE THEN MANUALLY INSERTED. AFTER AN ATTEMPTED REDUCTION, A STEM 11 IMPLANT WAS INS

  Patient problems: Limb Fracture

  MAUDE report 11946644 ↗
• MalfunctionOct 12, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE HANDLE OF THE ANTERIOR BROACH ADAPTER DEVICE WAS BROKEN. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS REPORTED THAT 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. 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 Consequences Or Impact To Patient

  MAUDE report 10667004 ↗