KINCISE™ 1011-01-101Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00845384018575), received between Jul 17, 2020 and Feb 9, 2026 — classified as 51 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (45 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 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY THE CROSS BAR ON THE SHELL/LINER IMPACTOR DEVICE BROKE OFF DURING IMPACTION. 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 24293969 ↗
• MalfunctionFeb 9, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY THE SHELL/LINER IMPACTOR DEVICE BROKE OFF DURING IMPACTION. 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 24293759 ↗
• MalfunctionApr 2, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE IMPACTOR DEVICE CRACKED AT THE T HANDLE AND BROKE INTO TWO PIECES. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21750727 ↗
• MalfunctionFeb 24, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SHELL/LINER IMPACTOR DEVICE SNAPPED AT THE ¿T¿. THERE WAS A TWO-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 21444245 ↗
• MalfunctionFeb 8, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE T-HANDLE OF THE IMPACTOR DEVICE BROKE INTO 3 SEPARATE PARTS AT THE T INTERSECTION OF THE DEVICE. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21340387 ↗
• MalfunctionJan 31, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING PRE-SURGERY, IT WAS OBSERVED THAT THE T-HANDLE CUP IMPACTOR IS STRIPPED INTO AND LOCKED INTO THE IMPACTOR. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21284945 ↗
• MalfunctionJan 30, 2025Material Fragmentation; Component Missing; Material Fragmentation; Component Missing

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE HANDLE ON THE DEVICE BROKE AT THE T-HANDLE JUNCTION INTO 3 PIECES. THERE WAS PATIENT INVOLVEMENT. 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 21277977 ↗
• MalfunctionOct 24, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE IMPACTOR DEVICE T-HANDLE BROKE AT THE INTERSECTION OF THE T INTO THREE PARTS. 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20521238 ↗
• MalfunctionSep 19, 2024Fracture; Material Fragmentation; Fracture; Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE KINCISE IMPACTOR DEVICE BROKE AT THE T-HANDLE JUNCTION. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO 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 20256709 ↗
• MalfunctionSep 16, 2024Fracture; Material Fragmentation; Fracture; Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE IMPACTOR DEVICE BROKE AT THE T-HANDLE JUNCTION. 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20226226 ↗
• MalfunctionSep 11, 2024Fracture; Material Fragmentation; Fracture; Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE ADAPTOR FOR THE IMPACTOR DEVICE HAD A BROKEN CUP INSERTED AND WAS BROKEN AT THE T HANDLE JUNCTION. THERE WERE NO DELAYS 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 20192558 ↗
• MalfunctionSep 11, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE ADAPTOR FOR THE IMPACTOR DEVICE BROKE AT THE T HANDLE JUNCTION. THERE WERE NO DELAYS 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 20192284 ↗
• MalfunctionJul 16, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE ADAPTOR FOR THE IMPACTOR DEVICE BROKE AT THE T COUPLING BECAUSE THAT AREA WAS NOT A SOLID PIECE. IT WAS REPORTED THAT THERE WERE NO DELAYS IN 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 19756043 ↗
• MalfunctionJun 17, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE KINCISE IMPACTOR DEVICE T-HANDLE CROSSBAR JUNCTION BROKE. 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 19547022 ↗
• MalfunctionJun 3, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE IMPACTOR DEVICE BROKE AT THE T-HANDLE INTERFACE WHILE IMPACTING. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR 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 19448143 ↗
• MalfunctionMay 16, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE KINCISE DEVICE HANDLE CAME APART DURING USE. IT WAS UNKNOWN IF THERE WAS A DELAY TO 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. 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 19331202 ↗
• MalfunctionApr 18, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE HANDLE OF THE IMPACTOR ADAPTOR DEVICE BROKE ON IMPACTION. IT WAS FURTHER REPORTED THAT THE CROSS PIECE OF THE METAL WAS COMPLETELY BROKEN UPON STRIKING THE HANDLE AND THE PIECE FELL ON THE FLOOR DURING THE SURGERY. IT WAS REPORTED THAT THERE WERE NO DELAYS IN 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 19137793 ↗
• MalfunctionApr 18, 2024Material Fragmentation; Device-Device Incompatibility; Material Fragmentation; Device-Device Incompatibility

  IT WAS REPORTED FROM AUSTRALIA THAT DURING PRE-PROCEDURE INSPECTION IT WAS OBSERVED THAT THE THREADING OF THE IMPACTOR DEVICE HAD BEEN CHIPPED OFF AND DENTED THEREFORE OTHER COMPONENTS COULD NOT BE SCREWED ON. 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 19136719 ↗
• MalfunctionApr 10, 2024Material Fragmentation; Material Fragmentation

  THIS IS REPORT 3 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 19080539 ↗
• MalfunctionMar 26, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE IMPACTOR DEVICE BROKE AND SNAPPED AT THE T-JOINT. IT WAS REPORTED THAT THERE WERE NO DELAYS IN 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 18978745 ↗
• MalfunctionNov 3, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE CUP INSERTER OF THE IMPACTOR DEVICE WAS CRACKED AND BENT BEYOND USE. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE DEVICE WAS BROKEN IN TWO PIECES AT THE T-HANDLE. 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 18066587 ↗
• MalfunctionAug 25, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE SHELL/LINER IMPACTOR DEVICE BROKE WHILE IMPACTING THE CUP. IT WAS FURTHER REPORTED THAT THE DEVICE BROKE INTO TWO PIECES AT THE JUNCTION THAT FORM A ¿T¿, WHILE THE SURGEON WAS MANIPULATING THE CUP ORIENTATION BY HAND PRIOR TO IMPACTION. IT WAS REPORTED THAT THERE WERE NO DELAYS IN 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 17622739 ↗
• MalfunctionAug 18, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE IMPACTOR DEVICE WAS BROKEN INTO TWO PIECES AT THE T-HANDLE. IT WAS REPORTED THAT THERE WERE NO DELAYS IN THE PROCEDURE DUE TO THE EVENT. 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17576745 ↗
• MalfunctionAug 14, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING PRE-SURGERY SET-UP IT WAS OBSERVED THAT THE CUP OF THE IMPACTOR DEVICE BROKE AT THE CROSS PIECE. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE DEVICE FAILED VISUAL INSPECTION DUE TO T-HANDLE BROKEN IN TWO OR MORE PIECES. 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 17541547 ↗
• MalfunctionAug 11, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE KINCISE ADAPTER HANDLE COULD NOT BE REMOVED FROM THE CUP IMPLANT AFTER IMPLANTING THE DEVICE. IT WAS REPORTED THAT AFTER PUTTING THE INSERTER AND CUP THROUGH THE WASHER AT THE HOSPITAL THE SALES REP WAS ABLE TO GET THE IMPLANT OFF THE CUP INSERTER, SINCE IT WAS SO HOT. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17512840 ↗