Sesamoid ® 20-8000-000-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024563636), received between Aug 2, 2021 and Feb 10, 2026 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2026Fracture

  IT WAS REPORTED THAT DURING A ROBOT-ASSISTED TOTAL KNEE ARTHROPLASTY, A FIXATION FLUTED PIN (3.2 MM X 80 MM) FRACTURED DURING REMOVAL FROM THE TIBIA, RESULTING IN A RETAINED FRAGMENT. INTRA-OPERATIVELY, THE PIN BROKE AS THE SURGEON ATTEMPTED TO REMOVE IT; A PORTION WAS RETRIEVED AND THE REMAINING SEGMENT EMBEDDED IN THE TIBIA WAS LEFT IN PLACE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24306009 ↗
• InjuryAug 7, 2025Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22737799 ↗
• InjuryOct 17, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE FIX TIBIAL PINS FRACTURED DURING A ROSA TKA PROCEDURE. THE TIPS BROKE WHILE INSERTING THE PINS INTO THE TIBIA. THE BROKEN TIPS WERE LEFT INSIDE THE PATIENT'S BONE, AND A CONTROL X-RAY WAS TAKEN AT THE END OF THE SURGICAL PROCEDURE. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE. AS NO ADDITIONAL INFORMATION OR PRODUCT IS AVAILABLE, WE ARE UNABLE TO PROVIDE FURTHER INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 20472561 ↗
• MalfunctionApr 3, 2024Fracture; Fracture

  IT WAS REPORTED PATIENT UNDERWENT AN INITIAL ROSA KNEE PROCEDURE. AFTER THE PROCEDURE, THE TRACKERS WERE REMOVED, AND A SMALL PIECE OF THE 80 MM FIX FLUTED PIN HAD BROKEN OFF AND WAS BELIEVED TO HAVE REMAINED IN THE PATIENT¿S POSTERIOR CORTEX. THE BROKEN TIP MEASURED AROUND 1MM. THE SURGEON EXPRESSED NO CONCERN AND DID NOT FEEL AN XR WAS NEEDED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19033178 ↗
• InjuryNov 29, 2023Fracture; Fracture

  IT WAS REPORTED WHEN REMOVING THE 80MM PIN TOWARD THE END OF THE SURGERY FROM THE TIBIA, THE TIP SNAPPED OFF AND REMAINED IN THE BONE. APPROXIMATELY 5MM OF THE TIP REMAINED IN THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 18229176 ↗
• MalfunctionApr 25, 2023Fracture; Fracture

  IT WAS REPORTED DURING AN INITIAL KNEE PROCEDURE, THE SURGEON PLACED THE PINS FOR THE NAVITRACKER INTO THE TIBIA. SUBSEQUENTLY, THE 80MM PIN BROKE OFF IN THE PROCESS. THE PIN WAS COMPLETELY REMOVED FROM THE TIBIA. A COMPETITOR MACHINE WITH QUICK-RELEASE FASTENER WAS USED TO PLACE THE PIN. NO PATIENT HARM OR IMPACT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16807332 ↗
• InjuryMay 25, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED DURING TKA USING ROBOTIC ASSISTED INSTRUMENTATION, A PIN SNAPPED WITHIN THE PATIENT. PROPER SURGICAL TECHNIQUE WAS USED WHEN INSERTING THE PINS INTO THE TIBIA. FIRST PIN WAS PLACE PROXIMALLY AND SECOND PIN DISTAL TO THAT. THE DISTAL PIN WENT THROUGH THE NEAR CORTEX FINE AND PROCEEDED TO 'STOP' PROGRESSING INTO THE BONE. WHEN THE SURGEON ATTEMPTED TO BACK THE PIN OUT AND INSPECT WHAT OCCURRED. HE NOTICED THAT THE PIN WAS BROKEN. IT WAS NOTED THAT THE PATIENT DID NOT HAVE UNUSUALLY DENSE BONE NOR WEAK BONE. THIS EVENT OCCURRED AT THE TIME OF PLACING THE TRACKERS PRIOR TO REGISTRATION. THERE WAS A 30-45 MINUTE DELAY IN PROCEDURE. ADDITIONAL SKIN INCISION AND PIN REQUIRED. THE SURGEON ATTEMPTED TO REMOVE THE PIN INTRA-OPERATIVELY BUT WAS UNABLE TO DO SO AS THE PIN ANCHORED INTO POSTERIOR CORTICAL BONE. NO KNOWN IMPACT TO THE PATIENT, AT THIS TIME THE PIN REMAINS IMPLANTED IN PATIENT. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14498905 ↗
• InjuryFeb 18, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A TKA UTILIZING ROSA KNEE INSTRUMENTATION THE TIP OF THE FIXATION PIN BROKE OFF UPON INSERTION INTO THE TIBIA. THE COMPONENT THAT BROKE OFF WAS RETAINED IN THE PATIENTS TIBIA AND WAS NOT REMOVED. NEW PINS WERE OPENED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADDITIONAL PATIENT IMPACT REPORTED AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13562081 ↗
• InjuryAug 2, 2021Fracture; Fracture

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 12262575 ↗