NA 74013480Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 20885556070929), received between Aug 20, 2018 and Nov 10, 2025 — classified as 6 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY THE TIP OF ONE (1) NONRIM SPEED PIN 65 STERILE BROKE OFF DURING REMOVAL. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23518543 ↗
• MalfunctionSep 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) NONRIM SPEED PIN 65 STERILE BROKE OFF IN ONE (1) MIS PIN DRIVER, ALL PIECES ACCOUNTED FOR, IT OCCURRED WHILE DRILLING THE PIN THROUGH A CUT GUIDE AND GOT BOUND UP, NO PIECES TO REMOVE FROM PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22985161 ↗
• InjuryMar 26, 2024Fracture; Improper or Incorrect Procedure or Method; Fracture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT, A PATIENT WHO HAD A PREVIOUS ACL REPAIR UNDERWENT A CORI ASSISTED TKA PROCEDURE, AND THEREFORE ALREADY HAD A SCREW IN THEIR TIBIA. DURING SURGERY, AN ADJUSTABLE TIBIA CUT GUIDE WAS ADJUSTED WITH A NONRIM SPEED PIN 65 STERILE AND THE SPEED PIN SNAPPED IN HALF WHEN IT HIT THE ACL SCREW THAT WAS IN THE TIBIA (THE PROXIMAL AND MEDIAL PIN HOLE ON THE FIXATION BLOCK). ANOTHER PIN WAS ADDED TO THE DISTAL PIN HOLE ON THE FIXATION BLOCK. THE SURGEON LATER USED A VICE GRIP AND OSTEOTOME TO REMOVE THE THREADS OF THE BROKEN PIN AND THE ACL SCREW FROM THE TIBIA, REQUIRING ADDITIONAL CUTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY, AFTER A SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Perforation; Rupture

  MAUDE report 18980038 ↗
• MalfunctionFeb 7, 2024Fracture; Separation Failure; Fracture; Separation Failure

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) NONRIM SPEED PIN 65 STERILE BENT AND GOT STUCK INSIDE OF A TIBIAL CUTTING GUIDE THREE DEG RIGHT. ADDITIONALLY, THE TIP OF THE NONRIM SPEED PIN 65 STERILE BROKE OFF INSIDE OF A MIS PIN DRIVER. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18663569 ↗
• MalfunctionJul 27, 2023Manufacturing, Packaging or Shipping Problem; Material Twisted/Bent; Manufacturing, Packaging or Shipping Problem; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION FOR A TKA, IT WAS FOUND THAT ONE (1) NONRIM SPEED PIN 65 STERILE WAS BENT OUT OF PACKAGE. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17410965 ↗
• MalfunctionJul 27, 2023Device Damaged Prior to Use; Material Twisted/Bent; Device Damaged Prior to Use; Material Twisted/Bent

  IT WAS REPORTED THAT DURING SET UP FOR A TKA, A PIN IN A NONRIM SPEED PIN 65 STERILE WAS BENT WHEN REMOVED FROM PACKAGING. BOX WAS NOT DAMAGED BEFORE OPENING. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17410963 ↗
• InjuryJun 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, 2 TO 3MM FROM THE TIP OF A NONRIM SPEED PIN 65 STERILE BROKE OFF. ON A POST-OPERATIVE X-RAY, IT WAS FOUND THAT THERE WAS A FOREIGN BODY IN THE FEMUR, THE BROKEN PIECE WAS NOT PLANNED TO BE REMOVED BECAUSE THE PIECE WAS LOCATED DEEP IN THE BONE.. THE PROCEDURE HAD BEEN FINISHED UNEVENTFULLY. CURRENT PATIENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 17137108 ↗
• InjuryMay 11, 2022Break; Break

  IT WAS REPORTED THAT THE TIP OF NONRIM SPEED PIN 65 STERILE BROKE OFF AND LODGED INTO SOFT TISSUE OF THE KNEE. THIS WAS NOTICED AFTER TKA SURGERY. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 14366116 ↗
• InjuryOct 11, 2021Break; Break

  IT WAS REPORTED DURING A TKA PROCEDURE, THAT 2 NONRIM SPEED PIN 65 STERILE BROKE OFF IN A PATIENTS KNEE WHEN THE SURGEON HIT THE SCREW IN BOTH THE FEMUR AND TIBIA. THE PIECE REMAINS INSIDE THE PATIENT, SURGEON WAS NOT ABLE TO RETRIEVE IT. PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE, NO DELAY REPORTED. AN INJURY IS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12611777 ↗
• InjuryOct 11, 2021Break; Break

  IT WAS REPORTED DURING A TKA PROCEDURE, THAT (2) NONRIM SPEED PIN 65 STERILE BROKE OFF IN A PATIENTS KNEE WHEN THE SURGEON HIT THE SCREW IN BOTH THE FEMUR AND TIBIA. THE PIECE REMAINS INSIDE THE PATIENT, SURGEON WAS NOT ABLE TO RETRIEVE IT. PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE, NO DELAY REPORTED. AN INJURY IS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12611758 ↗
• MalfunctionNov 19, 2019Flaked; Flaked

  IT WAS REPORTED THAT DURING SURGERY, AFTER THE DISTAL FEMORAL CUTTING, THERE WERE THE SHAVING SUBSTANCES. THE MARKING OF THE PIN WAS DAMAGED AND VANISHED, SO THE SHAVINGS WERE CONSIDERED THEY WERE FROM THE PIN. THIS ISSUE WAS FOUND AFTER SCREWING THE PIN AND DID NOT AFFECT THE SURGERY. EVERYTHING WAS REMOVED FROM PATIENT. DELAY LESS THAN 30 MINUTES AND NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9340507 ↗
• MalfunctionNov 19, 2019Flaked; Flaked

  IT WAS REPORTED THAT DURING SURGERY, AFTER THE DISTAL FEMORAL CUTTING, THERE WERE THE SHAVING SUBSTANCES. THE MARKING OF THE PIN WAS DAMAGED AND VANISHED, SO THE SHAVINGS WERE CONSIDERED THEY WERE FROM THE PIN. THIS ISSUE WAS FOUND AFTER SCREWING THE PIN AND DID NOT AFFECT THE SURGERY. EVERYTHING WAS REMOVED FROM PATIENT. DELAY LESS THAN 30 MINUTES AND NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9340368 ↗
• MalfunctionApr 1, 2019Illegible Information; Illegible Information

  IT WAS REPORTED THAT DURING SURGERY, AFTER THE DISTAL FEMORAL CUTTING, THERE WERE THE SHAVING SUBSTANCES. THE MARKING OF THE PIN WAS DAMAGED AND VANISHED, SO THE SHAVINGS WERE CONSIDERED THEY WERE FROM THE PIN. THIS ISSUE WAS FOUND AFTER SCREWING THE PIN AND DID NOT AFFECT THE SURGERY. EVERYTHING WAS REMOVED FROM PATIENT. DELAY LESS THAN 30 MINUTES AND NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8470815 ↗
• InjuryAug 20, 2018Break

  IT WAS REPORTED THAT TIP OF SPEED PIN (5MM FROM TIP) BROKE AND REMAINED IN FEMORAL. IT WAS FOUND DURING X-RAY CHECK IMMEDIATE POST-OPERATION. THE SURGEON DECIDED THAT BROKEN TIP LEFT IN PATIENT BECAUSE IT WAS LOCATED DIFFICULT REGION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7799518 ↗