NA 74013401Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 20885556071506), received between Oct 10, 2021 and Apr 16, 2026 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2026Fracture

  IT WAS REPORTED THAT DURING A TSA, AFTER REMOVING THE PINS AND ARRAYS, AN X-RAY WAS TOOK AND IT WAS NOTICED THAT THE TIP OF A NONRIM SPEED PIN 110 STERILE HAD BROKEN OFF INSIDE THE BONE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24895666 ↗
• InjuryFeb 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, IT WAS NOTICED THAT (B)(4) NONRIM SPEED PIN 110 STERILE BROKE OFF IN PATIENT'S TIBIA. THE PIN WAS LEFT IN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18707347 ↗
• InjuryJan 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A UKR SURGERY, IT WAS NOTICED THAT THE TIP OF ONE NONRIM SPEED PIN 110 STERILE, USED IN THE TIBIA FOR A CORI CASE, BROKE OFF AND 3-4MM WERE LEFT IN THE TIBIAL BONE. JUST NOTICED ON POST OP X-RAYS. THE PROCEDURE HAD BEEN COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT'S CURRENT HEATH STATUS IS GOOD. NO FURTHER INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18522166 ↗
• InjuryNov 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHILE USING THE NONRIM SPEED PIN 110 STERILE, A PIECE BROKE OFF IN THE TIBIA, AND REMAINS EMBEDDED IN THE BONE. THE PROCEDURE WAS COMPLETED, USING THE SAME DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18139173 ↗
• InjuryOct 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A BILATERAL TKR USING CORI ROBOTICS, WHEN THE FIRST SIDE OF THE BILATERAL (RIGHT) WAS COMPLETED AND ALL TRACKER PINS REMOVED BEFORE PROCEEDING TO THE LEFT KNEE. IT WAS NOTICED THAT THE TIP OF ONE (1) NONRIM SPEED PIN 110 STERILE WAS MISSING (ABOUT 4MM OF THE TIP). AT THE END OF THE CASE BEFORE FINAL CLOSURE OF THE SKIN, X-RAY (I/I) WAS BROUGHT IN TO CHECK THE RIGHT TIBIA TO SEE IF THE TIP OF THE PIN WAS LEFT IN THE BONE. THE IMAGES CONFIRMED THE TIP OF THE PIN WAS STILL EMBEDDED IN THE POSTERIOR TIBIAL CORTEX. THE PIN TIP WAS LEFT IN SITU AND THE SURGERY COMPLETED, AFTER A NON-SIGNIFICANT DELAY. NO POST OPERATIVE SYMPTOMS OR DISCOMFORT HAVE BEEN REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18031672 ↗
• InjuryOct 5, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A LEFT TKA W/WO PATELLA RESURFACING (LEFT) SURGERY, WHILE USING THE NONRIM SPEED PIN 110 STERILE, ITS TIP BROKE OFF INTO THE PATIENT'S BONE. THE PHYSICIAN DECIDED TO LEAVE THE PIN INSIDE OF THE BONE. IT IS UNKNOWN HOW LONG, IF ANY, SURGERY WAS PROLONGED AS CONSEQUENCE OF THE INCIDENT. THE PATIENT IS DOING WELL. NO COMPLICATION HAS BEEN REPORTED; NEXT VISIT WAS SCHEDULED FOR (B)(6) 2023.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 17882591 ↗
• MalfunctionJul 14, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE TIP OF A NONRIM SPEED PIN 110 STERILE WAS FOUND BROKEN. THIS WAS DISCOVERED BY REMOVING SAID PIN. THE PATIENT WAS X-RAYED AND NO PIECE WAS FOUND. SURGERY WAS FINISHED WITH THE SAME DEVICE. IT IS UNKNOWN IF THIS INCIDENT CAUSED A DELAY. NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15021937 ↗
• InjuryJul 7, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA, THE FIN PUNCH HIT THE NONRIM SPEED PIN 110 STERILE AND BENDING IT. AT THE END OF THE CASE, THE SURGEON NOTICED THAT THE PIN WAS BENT AND HAD TROUBLE REMOVING PIN. WHEN THE PIN WAS FINALLY REMOVED, IT WAS NOTICED THAT THE PART OF THE PIN WITH THE THREADS HAD BROKEN OFF INSIDE TIBIA. AN X-RAY WAS CALLED TO ENSURE THERE WAS NO FRACTURE, SURGEON DECIDED TO LEAVE THE PART OF THE PIN IN THE TIBIA. A DELAY OF LESS THAN 30 MINUTES OCCURRED DUE TO X-RAYS. THE PATIENT WAS NOT HARMED BEYOND THE PROBLEM REPORTED AND CURRENT STATUS IS UNKNOWN, ALTHOUGH SURGEON DOES NOT ANTICIPATE FUTURE PATIENT IMPACT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14946560 ↗
• InjuryOct 11, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE THREADED ENDS OF A NON RIMMED SPEED PIN 110MM STERILE BROKE AND A SMALL AMOUNT OF METAL (NO MORE THAN 5MM IN TOTAL SIZE) HAVE BEEN LEFT IN THE TIBIAL BONE OF THE PATIENT. SURGERY WAS PERFORMED, WITH A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 12611732 ↗
• InjuryOct 11, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE THREADED ENDS OF A NON RIMMED SPEED PIN 110MM STERILE BROKE AND A SMALL AMOUNT OF METAL (NO MORE THAN 5MM IN TOTAL SIZE) HAVE BEEN LEFT IN THE TIBIAL BONE OF THE PATIENT. SURGERY WAS PERFORMED, WITH A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12603053 ↗
• InjuryOct 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE THREADED ENDS OF A NON RIMMED SPEED PIN 110MM STERILE BROKE AND A SMALL AMOUNT OF METAL (NO MORE THAN 5MM IN TOTAL SIZE) HAVE BEEN LEFT IN THE TIBIAL BONE OF THE PATIENT. SURGERY WAS PERFORMED, WITH A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12603036 ↗
• InjuryOct 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE THREADED ENDS OF A NON RIMMED SPEED PIN 110MM STERILE BROKE AND A SMALL AMOUNT OF METAL HAVE BEEN LEFT IN THE TIBIAL BONE OF THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, OR IF THERE WAS ANY DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 12603030 ↗