NA 74013490Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 20885556071391), received between Apr 28, 2022 and Sep 22, 2026 — classified as 7 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Fracture” (16 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Fracture

  It was reported that, during an internal fixation, the tip of one (1) NONRIM SPEED PIN 80 STERIL had broken. It is unknown how the procedure was finished but not surgical delay was reported. No further complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855382 ↗
• MalfunctionAug 30, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50510862 ↗
• MalfunctionFeb 27, 2026Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING TKA SURGERY, WHILE PERFORMING THE PINNING OF THE FEMORAL CUTTING BLOCK, THE SURGICAL APPROACH WAS ANGLED DUE TO A BONE DEFECT, AT THE MOMENT OF INSERTING, THREE (3) NONRIM SPEED PIN 80 STERILE BENT. 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 24471646 ↗
• InjuryDec 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, WHEN INSTALLING THE LOCKING PIN OF THE 4-IN-1 THIGH CUTTING BLOCK, THE DRILLING TIP IN THE NONRIM SPEED PIN 80 STERILE BROKE SPONTANEOUSLY AT A DEPTH OF APPROXIMATELY 1.5 CM IN THE COLLATERAL FEMORAL CONDYLE - A FRAGMENT APPROXIMATELY 5 MM LONG. IT WAS IMPOSSIBLE TO REMOVE WITHOUT SIGNIFICANT BONE DESTRUCTION. ALTHOUGH, THE PORTION OF THE PIN WAS LEFT IN PATIENT¿S BONE. PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, WITH AN EQUIVALENT S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23821813 ↗
• InjurySep 10, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A TKA, AFTER THE FEMORAL INCISIONS WERE MADE AND THE CUTTING BLOCK WAS BEING REMOVED, THE NONRIM SPEED PIN 80 STERILE WAS PUSHED TOO QUICKLY, CAUSING IT TO GET LODGED INSIDE THE PATIENT'S FEMUR. IT IS UNKNOWN IF THERE WAS A DELAY. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 23022160 ↗
• MalfunctionAug 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT, WHILE PINNING THE FEMORAL CUTTING BLOCK IN A TKA SURGERY, THE SURGEON ANGLED HIS HAND WHEN INSERTING ONE (1) NONRIM SPEED PIN 80 STERILE, CAUSING IT TO BREAK. THE BROKEN PIECES WERE COMPLETELY REMOVED. THE PROCEDURE WAS RESUMED WITHOUT DELAY USING A SMITH AND NEPHEW BACKUP DEVICE, AND NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22787542 ↗
• MalfunctionAug 8, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, WHILE INSERTING ONE (1) NONRIM SPEED PIN 80 STERILE TO SECURE THE PROSTHESIS' CUTTING GUIDE, THE PIN BROKE, LEAVING THE THREADED PORTION INSIDE THE BONE. THE SURGEON IMMEDIATELY REMOVED THE EMBEDDED PORTION WITH A NEEDLE HOLDER AND LATER EXTRACTED THE REMAINING END WITH TWEEZERS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22750932 ↗
• InjuryMay 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA, IT WAS NOTICED THAT A BROKEN TIP OF (1) NONRIM SPEED PIN 80 STERILE REMAINED IN THE PATIENT'S BODY DUE TO POSTOPERATIVE X-RAY CHECK. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22069312 ↗
• MalfunctionApr 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, ONE (1) NONRIM SPEED PIN 80 STERILE WAS PLACED IN THE DISTAL GUIDE LOCKING DEVICE, BUT WHEN IT WAS REMOVED, THE TIP WAS NO LONGER PRESENT. DURING BONE CUTTING WITH THE BLOCK, THE TIP WAS IDENTIFIED AND HAD BEEN COMPLETELY REMOVED. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21932489 ↗
• MalfunctionMar 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE DISTAL CUT VALGUS GDE BRIDGE ADJUSTABLE AND DISTAL FEMUR CUTTING BLOCK WERE ATTACHED AND PINNED IN PLACE WITH 3 ADDITIONAL NONRIM SPEED PIN 80 STERILE. SURGEON THEN REMOVED THE LATERAL SIDE PIN HOLDING THE VARIABLE ANGLE VALGUS GUIDE TO THE DISTAL FEMUR. UPON ATTEMPTING TO DO THE SAME ON THE MEDIAL SIDE, THE SPEED PIN QK CONNECT ADAPTER AND POWER DRILL TORQUED VIOLENTLY IN SURGEON'S HAND (POWER DEVICE SET TO DRILL REVERSE). NONRIM SPEED PIN 80 STERILE HEAD HAD SNAPPED, WITH PIN HEAD LODGED INTO THE ATTACHMENT POINT ON THE PIN ADAPTOR. THE REST OF NONRIM SPEED PIN 80 STERILE REMAINED LODGED IN THE VARIABLE ANGLE VALGUS GUIDE. SURGEON ATTEMPTED TO REMOVE WITH POWER WIRE DRIVER ATTACHMENT, BUT NONRIM SPEED PIN 80 STERILE AGAIN SNAPPED, THIS TIME AT JUNCTION OF VARIABLE ANGLE VALGUS GUIDE FACE. THREADED TIP OF NONRIM SPEED PIN 80 STERILE REMAINED LODGED IN DEVICE, HOWEVER SURGEON WAS ABLE TO TAP THE VARIABLE ANGLE VALGUS GUIDE OFF DISTAL FEMUR WITH A MALLET AND BONE PUNCH. DISTAL FEMORAL CUT WAS PERFORMED AND THE PROCEDURE CONTINUED WITHOUT ANY FURTHER INCIDENT, AFTER A NON-SIGNIFICANT DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21585523 ↗
• InjuryNov 21, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A UKA SURGERY, UPON POST OPERATIVE X-RAY, A BROKEN NONRIM SPEED PIN 80 STERILE WAS DISCOVERED. THE SURGEON DECIDED TO RETURN TO THEATRE DIRECTLY AFTER THIS, ON THE SAME DAY, TO REMOVE BROKEN PIN. PATIENT CURRENT STATUS IS HEALTHY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20745415 ↗
• MalfunctionOct 15, 2024Break; Break

  IT WAS REPORTED THAT DURING A TKA WHEN FIXING THE FEMORAL GUIDE THE PIN OF ONE (1) NONRIM SPEED PIN 80 STERILE BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20450368 ↗
• MalfunctionOct 3, 2024Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED DURING A TKA SURGERY, WHEN MAKING THE TIBIAL CUTS, THE SURGEON BENT THE LOCKING PIN (NONRIM SPEED PIN 80 STERILE ) IN THE GIA AND IT BROKE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20359050 ↗
• InjuryMay 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE TIP OF A NONRIM SPEED PIN 80 STERILE (ABOUT 10 MM FROM THE TIP) BROKE OFF AND REMAINED IN THE PATIENT'S BODY. IT WAS FOUND DURING POSTOPERATIVE X-RAY CHECK. THE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Foreign Body In Patient

  MAUDE report 19309109 ↗
• MalfunctionNov 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A REVISION TKA, WHEN FIXING THE DISTAL GUIDE, A NONRIM SPEED PIN 80 STERILE BROKE FALLING OFF THE TABLE WITHOUT RISK TO THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18239378 ↗
• MalfunctionNov 11, 2023Break; Break

  IT WAS REPORTED THAT WHEN THE CUTTING BLOCK WAS BEING FIXED, THE NONRIM SPEED PIN 80 STERILE BROKE AND FELL ONTO THE PATIENT'S LEG AND ONTO THE FLOOR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18117165 ↗
• MalfunctionOct 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, WHEN FIXING THE FEMORAL CUTTING BLOCK A NONRIM SPEED PIN 80 STERILE BROKE. THE BROKEN PIN WAS REMOVED WITH TWEEZERS. THE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18029263 ↗
• MalfunctionJun 5, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TRAUMA SURGERY, WHEN THE LOCK WAS MADE, SURGEON REALIZED THAT (1) ONE NONRIM SPEED PIN 80 STERILE WAS BENT WHEN HE PINNED IT AND IT ENDED UP BREAKING. IN ADDITION, A SECOND NONRIM SPEED PIN 80 STERILE THAT WAS IN THE BOX, WAS MISSING THE TIP. THE PIECES OF THE BROKEN PIN WERE REMOVED WITH KELLY TWEEZERS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17057027 ↗
• MalfunctionApr 13, 2023Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, WHEN TRYING TO REMOVE THE NONRIM SPEED PIN 80 STERILET WITH THE DISTAL GUIDE FROM THE TIBIA, THE PIN BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16732119 ↗
• InjuryMar 28, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ARTHROPLASTY, THE TIP OF THE NONRIM SPEED PIN 80 STERILE BROKE. THE INCIDENT WAS NOTICED WHEN REMOVING THE MATERIAL FROM THE PATIENT. IT WAS NOT POSSIBLE TO REMOVE THE TIP FROM THE INSIDE. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16632608 ↗
• MalfunctionMar 23, 2023Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, A NONRIM SPEED PIN 80 STERILE BROKE WHEN FIXING THE SCREW IN THE FEMUR. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16607259 ↗
• InjuryApr 28, 2022Break; Break

  IT WAS REPORTED THAT DURING A TKA SURGERY, WHEN REMOVING THE NONRIM SPEED PIN 80 STERILE, IT BROKE IN HALF. PLIERS WERE USED TO REMOVE THE PIECE THAT WAS IN THE BONE, NO PIECES REMAINED IN PATIENT. THE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, AS THEY DID NOT LONGER NEEDED THE DEVICE. PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14246899 ↗