U2 Total Knee System 9404-2902Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 04719886892123), received between Feb 9, 2024 and Jan 28, 2026 — classified as 48 malfunctions.

The most frequently reported specific device problem is “Break” (48 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Break; Material Separation; No Apparent Adverse Event

  AFTER PUNCHING THE KNEE, DR. (B)(6) REMOVED THE TIBIAL TOWER WITH A SLAP HAMMER. AFTER THE TOWER AND BASEPLATE WERE REMOVED ONE OF THE TOWER SPIKES BROKE OFF. THE CASE WAS COMPLETED SUCCESSFULLY; THERE WAS NO DELAY IN THE CASE. THE PATIENT WAS UNAFFECTED, AND STANDARD SURGICAL PROTOCOL WAS FOLLOWED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24197198 ↗
• MalfunctionMay 21, 2025Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  THE SURGEON REMOVED TIBIAL TOWER COMPONENT #3~#5 AFTER APPLYING FORCE (PUNCHING) TO THE PATIENT'S KNEE. UPON INSPECTION, THE SURGEON FOUND THAT SPIKE WITHIN THE TIBIAL TOWER WAS BROKEN. THE BROKEN PIECE WAS FOUND IN THE BONE AND SAFELY EXTRACTED USING A RONGEUR TOOL. AFTER REMOVING THE BROKEN SPIKE, THE SURGEON PROCEEDED WITH THE REST OF THE PLANNED SURGICAL PROCEDURE. THE TIBIAL TOWER HAD ALREADY SERVED ITS INTENDED PURPOSE PRIOR TO ITS REMOVAL, SO THE BROKEN SPIKE DID NOT COMPROMISE THE SURGICAL OUTCOME. THERE WAS A 5-MINUTE DELAY IN THE SURGERY TO REMOVE THE BROKEN SPIKE, AGENT PROVIDED FEEDBACK THAT THIS DELAY DID NOT HAVE ANY IMPACT ON THE PATIENT OR THE OVERALL SUCCESS OF THE SURGERY. REPLACEMENT INSTRUMENT WAS SENT TO THE AGENT AND THE AGENT WAS REQUESTED TO RETURN THE BROKEN INSTRUMENT FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22067374 ↗
• MalfunctionMar 10, 2025Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  DURING A KNEE ARTHROPLASTY, TWO SPIKES ON THE TIBIAL TOWER INSTRUMENT BROKE WHILE BEING REMOVED AFTER PERFORMING KEEL PUNCH IMPACTION PROCEDURE. THE SURGEON IDENTIFIED THE TWO BROKEN SPIKES EMBEDDED IN THE BONE AND CAREFULLY EXTRACTED THE SPIKES FROM THE BONE AND CONTINUED WITH THE SURGERY, THERE WAS NO DELAY IN THE CASE. THIS COMPLICATION OCCURRED AFTER THE TIBIAL PREPARATION WAS COMPLETE, SO IT DID NOT AFFECT PATIENT OUTCOMES OR SIGNIFICANTLY DELAY THE OVERALL PROCEDURE. THE TIBIAL TOWER INSTRUMENT WAS NO LONGER NEEDED FOR THE REMAINING STEPS OF THE SURGERY. REPLACEMENT INSTRUMENT WAS SENT TO THE AGENT AND THE AGENT WAS REQUESTED TO RETURN THE BROKEN INSTRUMENT FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21556768 ↗
• MalfunctionJan 17, 2025Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  DURING A KNEE ARTHROPLASTY, ONE SPIKE ON THE TIBIAL TOWER INSTRUMENT BROKE WHILE BEING REMOVED AFTER PERFORMING KEEL PUNCH IMPACTION PROCEDURE. THE SURGEON IDENTIFIED THE ONE BROKEN SPIKE ON THE TIBIAL BASEPLATE AND CAREFULLY REMOVED THE SPIKE FROM THE TIBIAL BASEPLATE AND CONTINUED WITH THE SURGERY, THERE WAS NO DELAY IN THE CASE. THIS COMPLICATION OCCURRED AFTER THE TIBIAL PREPARATION WAS COMPLETE, SO IT DID NOT AFFECT PATIENT OUTCOMES OR SIGNIFICANTLY DELAY THE OVERALL PROCEDURE. THE TIBIAL TOWER INSTRUMENT WAS NO LONGER NEEDED FOR THE REMAINING STEPS OF THE SURGERY. REPLACEMENT INSTRUMENT WAS SENT TO THE AGENT AND THE AGENT WAS REQUESTED TO RETURN THE BROKEN INSTRUMENT FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21176314 ↗
• MalfunctionJan 17, 2025Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  THE SURGEON REMOVED THE TIBIAL TOWER COMPONENT #3~#5 AFTER APPLYING FORCE (PUNCHING) TO THE PATIENT'S KNEE. UPON INSPECTION, THE SURGEON FOUND THAT SPIKE WITHIN THE TIBIAL TOWER WAS BROKEN AND FELL ON THE BASEPLATE. AFTER REMOVING THE BROKEN SPIKE, THE SURGEON PROCEEDED TO COMPLETE THE CASE WITHOUT FURTHER INCIDENTS. THE TIBIAL TOWER HAD ALREADY SERVED ITS INTENDED PURPOSE PRIOR TO ITS REMOVAL, SO THE BROKEN SPIKE DID NOT COMPROMISE THE SURGICAL OUTCOME. THIS BRIEF DELAY DID NOT HAVE ANY IMPACT ON THE PATIENT OR THE OVERALL SUCCESS OF THE SURGERY. A REPLACEMENT INSTRUMENT WAS SENT TO THE AGENT AND THE AGENT WAS REQUESTED TO RETURN THE BROKEN INSTRUMENT FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21176268 ↗
• MalfunctionDec 26, 2024Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  THE SURGEON REMOVED TIBIAL TOWER COMPONENTS # 3~# 5 AFTER APPLYING FORCE (PUNCHING) TO THE PATIENT'S KNEE. UPON INSPECTION, THE SURGEON FOUND THAT TWO SPIKES WITHIN THE TIBIAL TOWER WAS BROKEN AND HAD BECOME EMBEDDED IN THE PATIENT'S BONE. THE SURGEON UTILIZED A SPECIALIZED TOOL CALLED A "RONGEUR" TO CAREFULLY REMOVE THE BROKEN SPIKES FROM THE PATIENT'S BONE. AFTER REMOVING THE BROKEN SPIKES, THE SURGEON PROCEEDED WITH THE REST OF THE PLANNED SURGICAL PROCEDURE. THE TIBIAL TOWER HAD ALREADY SERVED ITS INTENDED PURPOSE PRIOR TO ITS REMOVAL, SO THE BROKEN SPIKE DID NOT COMPROMISE THE SURGICAL OUTCOME. THIS BRIEF DELAY DID NOT HAVE ANY IMPACT ON THE PATIENT OR THE OVERALL SUCCESS OF THE SURGERY. REPLACEMENT INSTRUMENT WAS SENT TO THE AGENT AND THE AGENT WAS REQUESTED TO RETURN THE BROKEN INSTRUMENT FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21023805 ↗
• MalfunctionDec 26, 2024Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  DURING A KNEE ARTHROPLASTY, ONE SPIKE ON THE TIBIAL TOWER INSTRUMENT BROKE WHILE BEING REMOVED AFTER PERFORMING KEEL PUNCH IMPACTION PROCEDURE. THE SURGEON IDENTIFIED THE ONE BROKEN SPIKE ON THE TIBIAL BASEPLATE AND CAREFULLY REMOVED THE SPIKE FROM THE TIBIAL BASEPLATE AND CONTINUED WITH THE SURGERY, THERE WAS NO DELAY IN THE CASE. THIS COMPLICATION OCCURRED AFTER THE TIBIAL PREPARATION WAS COMPLETE, SO IT DID NOT AFFECT PATIENT OUTCOMES OR SIGNIFICANTLY DELAY THE OVERALL PROCEDURE. THE TIBIAL TOWER INSTRUMENT WAS NO LONGER NEEDED FOR THE REMAINING STEPS OF THE SURGERY. REPLACEMENT INSTRUMENT WAS SENT TO THE AGENT AND THE AGENT WAS REQUESTED TO RETURN THE BROKEN INSTRUMENT FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21023804 ↗
• MalfunctionOct 30, 2024Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  DURING A KNEE ARTHROPLASTY, A SPIKE ON THE TIBIAL TOWER INSTRUMENT BROKE WHILE BEING REMOVED FROM THE PREPARED TIBIA. THE SURGEON IDENTIFIED THE BROKEN FRAGMENT EMBEDDED IN THE BONE AND USED RONGUER TO CAREFULLY EXTRACT IT, RESULTING IN A BRIEF 2-MINUTE DELAY. THIS COMPLICATION OCCURRED AFTER THE TIBIAL PREPARATION WAS COMPLETE, SO IT DID NOT AFFECT PATIENT OUTCOMES OR SIGNIFICANTLY DELAY THE OVERALL PROCEDURE. THE TIBIAL TOWER INSTRUMENT WAS NO LONGER NEEDED FOR THE REMAINING STEPS OF THE SURGERY. REPLACEMENT INSTRUMENT WAS SENT TO THE AGENT AND THE AGENT WAS REQUESTED TO RETURN THE BROKEN INSTRUMENT FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20564460 ↗
• MalfunctionOct 30, 2024Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  DURING A KNEE ARTHROPLASTY, A SPIKE ON THE TIBIAL TOWER INSTRUMENT BROKE WHILE BEING REMOVED FROM THE PREPARED TIBIA. THE SURGEON IDENTIFIED THE BROKEN FRAGMENT EMBEDDED IN THE BONE AND USED CURETTES TO CAREFULLY EXTRACT IT, RESULTING IN A BRIEF 5-MINUTE DELAY. THIS COMPLICATION OCCURRED AFTER THE TIBIAL PREPARATION WAS COMPLETE, SO IT DID NOT AFFECT PATIENT OUTCOMES OR SIGNIFICANTLY DELAY THE OVERALL PROCEDURE. THE TIBIAL TOWER INSTRUMENT WAS NO LONGER NEEDED FOR THE REMAINING STEPS OF THE SURGERY. REPLACEMENT INSTRUMENT WAS SENT TO THE AGENT AND THE AGENT WAS REQUESTED TO RETURN THE BROKEN INSTRUMENT FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20564452 ↗
• MalfunctionAug 9, 2024Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  DURING A KNEE SURGERY, THE SPIKE ON THE TIBIAL TOWER INSTRUMENT BROKE WHILE BEING ATTACHED TO AND REMOVED FROM THE TIBIA TRIAL. THE BROKEN PIECE WAS FOUND IN THE BONE AND SAFELY EXTRACTED USING A RONGEUR TOOL. THIS INCIDENT DID NOT AFFECT THE PATIENT OR DELAY THE PROCEDURE, AS THE TIBIA PREPARATION WAS ALREADY COMPLETE AND THE INSTRUMENT WAS NO LONGER NEEDED. THE SURGERY CONCLUDED SUCCESSFULLY WITHOUT FURTHER COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19946670 ↗
• MalfunctionJun 7, 2024Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  SURGEON HAD COMPLETED HIS TIBIAL PUNCHING, AND WHILE REMOVING THE SIZE 3-5 TIBIAL TOWER, HE NOTICED ONE OF THE TOWER SPIKES HAD BROKEN OFF.THE SPIKE WAS LOCATED ON THE TIBIAL PLATEAU AND REMOVED.THE CASE WAS COMPLETED SUCCESSFULLY, THERE WAS NO DELAY IN THE CASE, AND THE PATIENT WAS UNAFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19483229 ↗
• MalfunctionJun 7, 2024Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  THE PEG ON THE TIBIAL TOWER BROKE DURING THE ATTACHMENT PROCESS TO THE TIBIA TRIAL. THE BREAKAGE OCCURRED WHILE TAPPING THE TOP OF THE TIBIAL TOWER AND REMOVING IT AFTER PREPARING THE TIBIA. THE BROKEN PEG WAS EASILY RECOVERED WHEN THE TIBIA TRIAL TRAY WAS REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS NOT AFFECTED. THERE WAS NO SIGNIFICANT DELAY, AS THE TIBIA PREPARATION WAS ALREADY COMPLETED, AND NO FURTHER USE OF THE INSTRUMENT WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19482804 ↗
• MalfunctionMay 22, 2024Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  SURGEON HAD COMPLETED HIS TIBIAL PUNCHING, AND WHILE REMOVING THE SIZE 3-5 TIBIAL TOWER, HE NOTICED ONE OF THE TOWER SPIKES HAD BROKEN OFF. THE SPIKE WAS LOCATED ON THE TIBIAL PLATEAU AND REMOVED. THE CASE WAS COMPLETED SUCCESSFULLY, THERE WAS NO DELAY IN THE CASE, AND THE PATIENT WAS UNAFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19373170 ↗
• MalfunctionMay 20, 2024Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  THE PEG ON THE TIBIAL TOWER BROKE DURING THE ATTACHMENT PROCESS TO THE TIBIA TRIAL. THE BREAKAGE OCCURRED WHILE TAPPING THE TOP OF THE TIBIAL TOWER AND REMOVING IT AFTER PREPARING THE TIBIA. THE BROKEN PEG WAS EASILY RECOVERED WHEN THE TIBIA TRIAL TRAY WAS REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS NOT AFFECTED. THERE WAS NO SIGNIFICANT DELAY, AS THE TIBIA PREPARATION WAS ALREADY COMPLETED, AND NO FURTHER USE OF THE INSTRUMENT WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19349376 ↗
• MalfunctionMay 8, 2024Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  THE PEG ON THE TIBIAL TOWER BROKE DURING THE ATTACHMENT PROCESS TO THE TIBIA TRIAL. THE BREAKAGE OCCURRED WHILE TAPPING THE TOP OF THE TIBIAL TOWER AND REMOVING IT AFTER PREPARING THE TIBIA. THE BROKEN PEG WAS EASILY RECOVERED WHEN THE TIBIA TRIAL TRAY WAS REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS NOT AFFECTED. THERE WAS NO SIGNIFICANT DELAY, AS THE TIBIA PREPARATION WAS ALREADY COMPLETED, AND NO FURTHER USE OF THE INSTRUMENT WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19271535 ↗
• MalfunctionMay 2, 2024Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  AFTER COMPLETING THE TIBIAL KEEL PREPARATION, DR. REMOVED THE TIBIAL TOWER USING THE SLOTTED HAMMER WITH THE PUNCH AND PUNCH ADAPTER INSIDE THE TOWER. AFTER INSPECTION IT WAS NOTED THE TIBIAL SPIKE HAD BROKEN. IT WAS FOUND IN THE PATIENT'S TIBIA WHERE THE ORIGINAL IMPACTION OCCURRED. THE SPIKE WAS SUCCESSFULLY REMOVED USING A KOCHER CLAMP. IT WAS STATED THIS PATIENT HAD "HARD BONE". THERE WAS AN APPROXIMATE 1-MINUTE DELAY IN THE CASE, AND THE CASE WAS COMPETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19235742 ↗
• MalfunctionMay 2, 2024Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  AFTER PUNCHING THE KNEE, DR. REMOVED THE TIBIAL TOWER WITH A SLAP HAMMER. AFTER THE TOWER AND BASEPLATE WERE REMOVED, ONE OF THE TOWER SPIKES BROKE OFF. THE CASE WAS COMPLETED SUCCESSFULLY, THERE WAS NO DELAY IN THE CASE. THE PATIENT WAS UNAFFECTED, THE STANDARD SURGICAL PROTOCOL WAS FOLLOWED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19235740 ↗
• MalfunctionApr 22, 2024Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  THE PEG ON THE TIBIAL TOWER BROKE DURING THE ATTACHMENT PROCESS TO THE TIBIA TRIAL. THE BREAKAGE OCCURRED WHILE TAPPING THE TOP OF THE TIBIAL TOWER AND REMOVING IT AFTER PREPARING THE TIBIA. THE BROKEN PEG WAS EASILY RECOVERED WHEN THE TIBIA TRIAL TRAY WAS REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS NOT AFFECTED. THERE WAS NO SIGNIFICANT DELAY, AS THE TIBIA PREPARATION WAS ALREADY COMPLETED, AND NO FURTHER USE OF THE INSTRUMENT WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19160183 ↗
• MalfunctionApr 18, 2024Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  AFTER THE SURGEON COMPLETED HIS TIBIAL KEEL PUNCH, THE 3-5 TIBIAL TOWER WAS REMOVED FROM THE TIBIA. UPON INSPECTION, ONE OF THE TIBIAL TOWER SPIKES HAD BROKEN OFF AND REMAINED IN TIBIAL PLATEAU. THE BROKEN SPIKE WAS REMOVED USING A KOCHER CLAMP. THERE WAS A 1-MINUTEDELAY IN THE CASE. THE PATIENT WAS UNAFFECTED, AND THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19131693 ↗
• MalfunctionApr 18, 2024Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  DR. REMOVED THE TIBIAL TOWER USING THE SLOTTED HAMMER WITH THE PUNCH AND PUNCH ADAPTER INSIDE THE TOWER PER STANDARD SURGICAL PROTOBOL AFTER PREPARING THE TIBIAL KEEL. UPON INSPECTION IT WAS A NOTED BOTH ANTERIOR SPIKES ON THE TIBIAL TOWER HAD BROKEN, BOTH SPIKES REMAINED IN THE TIVIAL PLATEAU AND WERE REMOVED USING A KOCHER CLAMP. THE SURGEON SAID THIS PATIENT HAD HARD BONE. THERE WAS A MINIMAL DELAY INT HE CASE TO REMOVE THE SPIKES, AND CASE WAS COMPETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19131677 ↗
• MalfunctionApr 18, 2024Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  DR. IMPACTED THE TOWER, DRILLED AND PUNCHED THE TIBIA FOLLOWING THE STANDARD SURGICAL PROTOCOL. ONCE THE TOWER WAS REMOVED FROM THE TIBIA USING THE SLOTTED HAMMER, DR. NOTED ONE OF THE TOWER SPIKES HAD BROKEN OFF AND REMAINED IN THE TIBIA. A KOCHER CLAMP WAS USED TO REMOVE THE BROKEN SPIKED FROM THE TIBIA, ADDING APPROXIMATELY 1 MINUTE TO THE CASE WITHOUT FURTHER INCIDENT. THE PATIENT WAS UNAFFECTED AND THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19131664 ↗
• MalfunctionApr 18, 2024Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  DR. REMOVED THE TIBIAL TOWER USING THE SLOTTED HAMMER WITH THE PUNCH AND PUNCH ADAPTER INSIDE OF THE TOWER. AFTER HANDING OFF THE ASSEMBLY TO THE SURGICAL TECH, THE TECH NOTICED ONE OF THE SPIKES HAD BROKEN OFF AND WAS LYING BESIDE THE ASSEMBLY ON THE MAYO STAND. STANDARD SURGICAL PROTOCOL WAS FOLLOWED, THERE WAS NO DELAY TO THE CASE, THE PATIENT WAS NOT AFFECTED AND THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19131655 ↗
• MalfunctionApr 18, 2024Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  PATIENT HAD SCLEROTIC BONE ON THE TIBIAL PLATEAU, AND THERE WAS DIFFICULTY SEATING THE TIBIAL TOWER ONTO THE BASEPLATE. ONCE SEATED AND TIBIAL PREP HAD BEEN COMPLETED, DR. REMOVED THE TOWER. ONE OF THE TIBIAL TOWER SPIKES REMAINED IN THE TIBIA AND WAS REMOVED WITH A RONGEUR. THERE WAS A 30-SECOND DELAY TO THE CASE, AND IT WAS COMPLETED SUCCESSFULLY. STANDARD SURGICAL PROTOCOL WAS FOLLOWED, AND THE PATIENT WAS UNAFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19131654 ↗
• MalfunctionApr 18, 2024Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  THE SURGEON WAS PREPARING TO REMOVE THE TIBIA TOWER FROM THE BASEPLATE AND THE PEG BROKE OFF. THE PEG WAS DETECTED AND REMOVED WITHIN 30 SECONDS. THERE WAS NO DELAY TO THE CASE AND THE SURGERY WAS COMPLETED WITHOUT ANY ISSUE'S OR DELAY'S AS THE INSTRUMENT HAS ALREADY PERFORMED ITS FUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19131653 ↗
• MalfunctionApr 18, 2024Break; Material Separation; No Apparent Adverse Event; Break; Material Separation; No Apparent Adverse Event

  AFTER COMPLETING HIS TIBIAL KEEL PUNCH, THE SURGEON REMOVED THE 3-5 TIBIAL TOWER FROM THE TIBIA. AFTER INSPECTING THE TOWER, IT WAS NOTED ONE OF THE TOWER FIXATION SPIKES HAD BROKEN AND REMAINED IN TIBIAL PLATEAU. A KOCHER CLAMP WAS USED TO REMOVE THE BROKEN SPIKE. THERE WAS A 1-MINUTE DELAY IN THE CASE, THE PATIENT WAS UNAFFECTED, AND THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19131652 ↗