NA 74013489Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 03596010627278), received between Aug 12, 2020 and Dec 22, 2025 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Break” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Fracture; Separation Failure; Fracture; Separation Failure

  IT WAS REPORTED THAT, DURING A TKA SURGERY ONE (1) UNKN MEMPHIS RECON KNEE INSTR BECAME LODGED IN ONE (1) DISTAL FEMUR CUTTING BLOCK AND SUBSEQUENTLY SNAPPED OFF THE CONNECTION END IN THE SPEED PIN DRIVER. NO INJURY TO PATIENT. NO PARTS WERE LEFT BEHIND IN THE PATIENT; ALL WERE ACCOUNTED FOR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT LEFT SURGERY IN GOOD HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863291 ↗
• MalfunctionDec 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, THE TIP OF A (1) SPEED PIN QK CONNECT ADAPTER BROKE OFF INSIDE THE PIN DRIVER. IT WAS NOT POSSIBLE TO REMOVE THE TIP. 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 20859901 ↗
• MalfunctionMay 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT ONE (1) SPEED PIN QK CONNECT ADAPTER NO LONGER HELD PINS. THE PIN FELL OUT OF THE DRIVER BECAUSE THE HOLDING MECHANISM NO LONGER WORKED. NOTHING FELL INTO THE 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 19411678 ↗
• MalfunctionDec 22, 2023Fracture; Separation Failure; Fracture; Separation Failure

  IT WAS REPORTED THAT DURING A TKA SURGERY THE SPEED PIN QK CONNECT ADAPTER ITSELF BROKE INTO THE GII MIS DCF DISTAL CUT BLK, SO IT ALSO BECAME UNUSABLE. THE PROCEDURE HAD BEEN COMPLETED, 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 18383316 ↗
• MalfunctionJun 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, WHILE THE QUICK PIN ADAPTOR WAS BEING USED THE SPEED PIN QK CONNECT ADAPTER THAT WAS INSIDE, BROKE. AS CONSEQUENCE OF THIS BREAKAGE THE PIN WAS NOT ABLE TO BE PULLED OUT. IN ADDITION, THE PIECE WILL NO LONGER HOLD ANY SCREWS. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14777314 ↗
• MalfunctionSep 14, 2021Break; Break

  IT WAS REPORTED THAT ONE SPEED PIN QK CONNECT ADAPTER BROKE DURING WASH. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12471205 ↗
• MalfunctionSep 3, 2021Break; Break

  IT WAS REPORTED THAT A SPEED PIN QUICK CONNECT ADAPTER BROKE DURING WASH. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12425171 ↗
• MalfunctionSep 3, 2021Break; Break

  IT WAS REPORTED THAT A SPEED PIN QUICK CONNECT ADAPTER BROKE DURING WASH. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12425157 ↗
• MalfunctionAug 5, 2021Break; Break

  IT WAS REPORTED THAT, A SPEED PIN QK CONNECT ADAPTER WAS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285679 ↗
• MalfunctionJun 4, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A TKA, IT WAS NOTICED THAT 2 SPEED PIN QK CONNECT ADAPTERS WOULD NOT LONGER RELIABLY HOLD PINS. THERE WAS A DELAY OF 30 MINUTES OR LESS AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11943716 ↗
• MalfunctionJun 4, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A TKA, IT WAS NOTICED THAT 2 SPEED PIN QK CONNECT ADAPTERS WOULD NOT LONGER RELIABLY HOLD PINS. THERE WAS A DELAY OF 30 MINUTES OR LESS AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942739 ↗
• MalfunctionApr 18, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING TKA SURGERY, THE CAPTURE OF THE SPEED PIN QK CONNECT ADAPTER WAS INSUFFICIENT TO HOLD PINS. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO SURGICAL DELAY AND NO INJURY TO THE PATIENT WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683502 ↗
• MalfunctionApr 11, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE INSERTER TOOL HAS A BROKEN SPRING ((B)(4)), THE PCL RETRACTOR IS BENT ((B)(4)), THE GOLD BUTTON HANDLE WILL NOT GRIP THE TRIAL PROPERLY ((B)(4)) AND THE SPEED PIN DRIVER DOES NOT HOLD PIN PROPERLY ((B)(4)). NO CASE OR PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646852 ↗
• MalfunctionMar 25, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT, DURING SETUP OR INSPECTION IT WAS NOTICED THAT THESE INSTRUMENTS SHOWED AN OVERABUNDANCE OF BIO-FILM THAT HAS BUILT UP ON THE INSTRUMENTS OVER THE YEARS. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572452 ↗
• MalfunctionFeb 21, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT SPEED PIN QUICK CONNECT ADAPTER WAS NOT PROPERLY HOLDING PINS. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11356737 ↗
• MalfunctionFeb 21, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT SPEED PIN QUICK CONNECT ADAPTER WAS NOT PROPERLY HOLDING PINS. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11356736 ↗
• MalfunctionDec 16, 2020Break; Break

  IT WAS REPORTED THAT, THE BUMPER OF A JOURNEY FEM IMPACT BUMPER RIGHT CAPTURE KNOBS IS BROKEN, THE FLEX SPACER IS CRACKED, THE SPEED PIN DRIVER STRIPPED OUT AND THE PCL RETRACTOR IS BENT. NO PATIENT HARMED, AND NO INJURY REPORTED BECAUSE THIS WAS FOUND DURING SERVICE AND REPAIR. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11015580 ↗
• InjuryAug 12, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT DURING SURGERY THE SPEED PIN QK CONNECT ADAPTER GOT STRIPPED. NO DELAY REPORTED. A S&N BACK UP DEVICE WAS AVAILABLE. ANY OTHER ISSUE THAT COULD AFFECT THE PATIENT'S CONDITION WAS NOT REPORTED BY THIS EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10397397 ↗