Fix Fluted Pin 3.2 x 150 mm Sterile 20-8000-000-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00889024563629), received between Dec 21, 2021 and Jan 6, 2026 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (9 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026Fracture

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY, THE TIP OF A NAVIGATION PIN FRACTURED WHILE SECURING A FEMORAL TRACKER, RESULTING IN A RETAINED FRAGMENT. DURING TRACKER PLACEMENT ON THE FEMORAL SIDE USING COMPUTER-ASSISTED INSTRUMENTATION, THE PATIENT¿S BONE WAS DESCRIBED AS HARD, AND THE PIN TIP FRACTURED BY APPROXIMATELY 5 MM, WITH THE FRAGMENT REMAINING IN THE FEMUR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23974191 ↗
• InjuryAug 1, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING INSERTION OF A FEMORAL TRACKER PIN AT ROSA TOTAL KNEE ARTHROPLASTY, THE TIP BROKE OFF AND REMINED IN THE CORTICAL BONE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 22687969 ↗
• InjuryJun 13, 2025Fracture; Fracture

  IT WAS REPORTED THAT AT THE END OF THE SURGERY, THE SURGEON WANTED TO REMOVE THE FEMORAL PINS. AFTER HE MANAGED TO REMOVE THE PIN, HE FOUND THAT ITS TIP WAS BROKEN. HE PERFORMED AN X-RAY AND FOUND THAT THE BROKEN TIP REMAINED IN THE BONE. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22201686 ↗
• InjuryMar 24, 2025Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21682637 ↗
• InjuryFeb 25, 2025Fracture; Fracture

  IT WAS REPORTED THE CAS FIX PIN BROKE OFF IN PATIENT'S FEMUR. THE FRAGMENT WAS NOT RETRIEVED AND REMAINS IN THE PATIENT. THERE HAVE BEEN NO REPORTS OF MEDICAL INTERVENTION DUE TO THIS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 21460786 ↗
• InjuryDec 30, 2024Fracture; Fracture

  NO FURTHER INFORMATION IS AVAILABLE REGARDING THE REPORTED EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21039573 ↗
• InjuryDec 30, 2024Fracture; Fracture

  NO FURTHER INFORMATION IS AVAILABLE REGARDING THE REPORTED EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21039555 ↗
• InjuryApr 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT A TOTAL KNEE ARTHROPLASTY WAS PERFORMED WITH ROSA KNEE AND WHEN REMOVING A FIXED FLUTED PIN, THE TIP PART BROKE AND IT REMAINED IN THE PATIENT BODY. THE SURGEON DECIDED NOT REMOVE THE TIP WITH HIS DISCRETION BASED ON THE RISK TO REMOVE. IT WAS NOTED THAT THERE IS NO HARM OR IMPACT TO THE PATIENT DUE TO THE FRACTURED PIN REMAINING AND THE PATIENT IS NOT EXPERIENCING ANY POST OPERATIVE PAIN. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19049990 ↗
• InjuryDec 19, 2023Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18354332 ↗
• InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A PARTIAL ARTERY RUPTURE AND SUBSEQUENT BLEEDING DURING A TKA AFTER THE SURGEON INSERTED THE SPACER INTO EXTENSION. THE PROCEDURE WAS DELAYED BY 120 MINUTES FOR VASCULAR INTERVENTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Rupture

  MAUDE report 17697957 ↗
• InjuryDec 19, 2022Break; Break

  IT WAS REPORTED THAT TOTAL KNEE ARTHROPLASTY WAS PERFORMED WITH ROSA KNEE. WHEN FIXED NAVI-TRACKER TO THE PATIENT FEMORAL BONE WITH THE PINS, SURGEON HAD A HARD TIME TO INSERT THEM BECAUSE THE PATIENT BONE QUALITY WAS VERY GOOD. WHEN THE SURGEON REMOVED THEM TO RE-INSERT, ONE OF THEM BROKE AT THE TIP. SUBSEQUENTLY, ANOTHER PIN WAS USED TO COMPLETE THE PROCEDURE. POSTOPERATIVELY, THE BROKEN TIP WAS SEEN ON X-RAY. NO REVISION IS PLANNED. NO ADDITIONAL INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 16005571 ↗
• InjuryNov 2, 2022Break; Break

  IT WAS REPORTED THAT A BREAKAGE OF A FEMORAL PIN WHICH IS USED TO ATTACH THE FEMORAL NAVITRACKER. THE TIP OF THE PIN REMAINED IN THE PATIENT'S FEMUR. ATTEMPTS ARE BEING MADE AND ADDITIONAL INFORMATION THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 15714056 ↗
• InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE EVENT OCCURRED APPROXIMATELY 14 DAYS AFTER AN INITIAL KNEE OPERATION FOR PLACEMENT OF THE FEMORAL TRACKER, PATIENT WAS ADMITTED WITH A DISTAL FEMORAL FRACTURE IN LINE WITH THE PIN TRACTS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Bone Fracture(s)

  MAUDE report 15698131 ↗
• InjuryJan 28, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A TKA SURGERY USING ROSA INSTRUMENTATION, THE FEMORAL PIN CRACKED WHILE DRILLING AND PART OF THE PIN WAS LOST IN THE PATIENT'S FEMUR. NEW PINS WERE OPENED AND THE PROCEDURE CONTINUED. AFTER THE PROCEDURE, AN X-RAY WAS TAKEN AND THE SURGEON DECIDED TO LEAVE THE FRAGMENT INSIDE THE PATIENT. THERE WAS NO ADDITIONAL PATIENT IMPACT REPORTED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13388686 ↗
• InjuryDec 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE EVENT OCCURRED AFTER AN INITIAL KNEE OPERATION AND PATIENT WAS OPERATED WITH A PERIPROSTHETIC PLATE DUE TO A STRESS FRACTURE OF THE LEFT FEMUR. SURGICAL REPORT DETAILS THAT THE FRACTURE OCCURRED AT THE FEMORAL FICHES WHICH ARE THE PINS USED IN ROSA INSTRUMENTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Bone Fracture(s)

  MAUDE report 13053696 ↗