NA 74013471Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20885556069985), received between Nov 13, 2020 and Nov 18, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2023Fracture; Mechanical Jam; Fracture; Mechanical Jam

  IT WAS REPORTED THAT DURING A TKA, USING A SPEED PIN QK CONNECT ADAPTER, WHEN CONNECTING THE THREADED RIM SPEED PIN 45MM STERILE TO THE FEMORAL CUTTING GUIDE, IT BROKE AND BECAME STUCK IN THE PIN GUIDE. NO PIECES FELL INSIDE OF THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18166917 ↗
• InjuryJul 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A TRIAL TIBIA TRAY WAS INSERTED AND PINNED IN PLACE TO CONFIRM SIZING AND ROTATION. THIS WAS NOTED TO JUST AVOID THE METAL TIBIAL INTERFERENCE SCREW, SO IT DID NOT HAVE TO BE EXTRACTED. THE ANTERIOR RIM SPEED PIN 45MM STERILE THAT WAS DRILLED CONTACTED THE INTERFERENCE SCREW AND SNAPPED, BUT THE RETAINED SEGMENT WAS THREADED AND BURIED IN BONE SO WAS LEFT IN PLACE SO AS NOT TO DISRUPT ANY OF THE PROXIMAL METAPHYSEAL BONE. IT IS UNKNOWN IF SURGERY WAS DELAYED AS CONSEQUENCE OF THE ISSUE. THE PATIENT IS DOING WELL AND HAS BEEN WORKING WITH PHYSICAL THERAPY TWICE A WEEK. HE CONTINUES TO HAVE STIFFNESS THAT IMPROVES AFTER EXERCISE; MOST LIKELY DUE TO HIS PREVIOUS KNEE SURGERY. X-RAYS OF THE RIGHT KNEE DEMONSTRATE THE TOTAL KNEE ARTHROPLASTY PROSTHESIS IN GOOD POSITION WITH NO EVIDENCE OF LOOSENING, OSTEOLYSIS, OR SUBSIDENCE NOTED. GOOD ALIGNMENT IS NOTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17249122 ↗
• MalfunctionAug 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHILE PLACING A RIM SPEED PIN 45MM STERILE INTO A GII MIS DCF AP CT BLK 8, THE HEAD OF THE PIN BROKE OFF IN THE SPEED PIN QK CONNECT ADAPTER. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, USING A SMITH AND NEPHEW BACK UP DEVICE. NO INJURY TO PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15141789 ↗
• InjuryNov 13, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DURING TOTAL KNEE ARTHROPLASTY THE SPEEDPIN HEAD WORN AWAY, MAKING IT IMPOSSIBLE TO REMOVE FROM THE CUTTING BLOCK WITH A DRILL. A PIN PULLER WAS USED TO TWIST IT OUT. THERE WAS A DELAY REPORTED OF LESS THAN OR EQUAL TO 30 MINUTES. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACKUP DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10840403 ↗