Navio PFSR101092Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00885556628713), received between Oct 24, 2019 and Jul 24, 2020 — classified as 13 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE, TWO NAVIO SOFT TISSUE PROTECTORS HAD A BONE PIN STUCK AND THERE ARE DIFFICULT TO SEPARATE. THE PROCEDURE WAS CONTINUED WITH MANUAL INSTRUMENTATION AND THERE WERE NO DELAYS. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10319404 ↗
• InjuryJul 24, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE, TWO NAVIO SOFT TISSUE PROTECTORS HAD A BONE PIN STUCK AND THERE ARE DIFFICULT TO SEPARATE. THE PROCEDURE WAS CONTINUED WITH MANUAL INSTRUMENTATION AND THERE WERE NO DELAYS. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10319392 ↗
• InjuryFeb 22, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING PLACEMENT OF THE TIBIAL ARRAY PINS, A PIN BECAME LODGED IN THE TISSUE PROTECTOR. THIS WAS REMOVED MANUALLY, HOWEVER IT WAS UNABLE TO DISLODGE THE PIN FROM THE TISSUE PROTECTOR. A SECOND TRAY WAS OPENED AND ANOTHER TISSUE PROTECTOR WAS GIVEN TO THE SURGEON. WHILE ATTEMPTING TO PLACE AN ARRAY PIN WITH THE SECOND TISSUE PROTECTOR, THE PIN ALSO BECAME LODGE IN THE PROTECTOR. THE PINS WERE PLACED MANUALLY AND THE CASE PROCEEDED WITHOUT INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9742783 ↗
• MalfunctionFeb 13, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BONE PIN WAS PLACED BUT THE TISSUE PROTECTOR GOT STUCK ON THE PIN. THE FRONT PIN AND SCREW IT OUT OF THE BONE. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9706424 ↗
• MalfunctionFeb 13, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SCRUB TECH AND RECON REP THAT THE TISSUE PROTECTOR WAS SLIGHTLY BENT ON ONE SIDE. THE PIN SLID NICELY THROUGH ONE GUIDE, BUT HAD A DIFFICULT TIME SLIDING THROUGH THE OTHER. THERE WAS NO PATIENT INVOLVEMENT. DEVICE WAS NOT DURING USE WHEN EVENT OCCURRED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9706213 ↗
• MalfunctionFeb 13, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING TKA SURGEON PUSHED TISSUE PROTECTOR DOWN INTO PATIENTS LEG WHILE DRILLING BONE PIN ON TIBIA AND AFTER COMPLETING SECOND BONE PIN DRILLING, THE TISSUE PROTECTOR GOT STUCK. ATTEMPTED TO POUND AND PRY IT OFF, BUT AFTER SEVERAL ATTEMPTS, GOT IT TO BUDGE AND IT CAME OFF. BONE PIN BROKE AT TOP WHILE SURGEON TRIED TO PULL OUT WITH DRILL. IT IS UNKNOWN THE LENGHT OF THE SURGICAL DELAY AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9706206 ↗
• InjuryFeb 6, 2020Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT DURING SURGERY THE FIRST BONE PIN WAS INSERTED IN FEMUR THROUGH THE TISSUE PROTECTOR AND BECAME STUCK WHEN DOCTOR TRIED TO REMOVE THE PROTECTOR. TRIED TO BACK OUT THE BONE PIN BY REVERSING THE DRILL AND THE HEAD OF THE PIN SNAPPED OFF INTO THE PIN DRIVER. THIS LEFT THE BROKEN PIN INSIDE THE TISSUE PROTECTOR AND PIN STILL STUCK IN FEMUR. IT WAS NOTICED THE PIN WOULD NOT TURN WITHIN THE PROTECTOR AND THEREFORE THE ONLY WAY FOR DOCTOR TO REMOVE THE PIN WAS TO TURN THE ENTIRE TISSUE PROTECTOR AROUND ENOUGH TIMES TO UNTHREAD THE PIN MANUALLY FROM THE FEMUR. DELAY OF 30 MINUTES AND NO PATIENT INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9677451 ↗
• InjuryFeb 6, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING SURGERY DOCTOR PLACED THE FIRST BONE PIN THROUGH THE SOFT TISSUE PROTECTOR AND PROCEEDED TO PLACE THE SECOND. UPON COMPLETING THE SECOND PIN PLACEMENT, ATTEMPTED TO REMOVE THE SOFT TISSUE PROTECTOR BUT IT WAS STUCK. ATTEMPTED TO USE A MALLET AND APPLY UPWARD FORCE BUT HAD NO SUCCESS. THE SECOND PIN PLACED HAD TO BE REMOVED AND THE PIN REMAINED STUCK INSIDE SOFT TISSUE PROTECTOR. ANOTHER PIN WAS THEN PLACED IN THE ORIGINAL GOLE MADE WITHOUT THE USE OF A SOFT TISSUE PROTECTOR. DELAY OF LESS THAN 30 MINUTES INVOLVED AND NO PATIENT INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9677449 ↗
• InjuryFeb 6, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING SURGERY WHILE PLACING THE SECOND BONE SCREW (PIN) IN THE TIBIA, THE BONE SCREW BECAME STUCK IN THE TISSUE PROTECTOR AS THE SECOND CORTEX WAS ENGAGED. DOCTOR WAS UNABLE TO SLIDE THE TISSUE PROTECTOR OFF OF THE BONE SCREW. THE BONE SCREW WAS BENT AND THE TOP OF IT BROKE OFF IN THE PIN DRIVER. THE BONE SCREW IS STILL STUCK IN THE TISSUE PROTECTOR. FIRST BONE SCREW WAS REMOVED AND TISSUE PROTECTOR WAS ROTATED IN ORDER TO BACK THE SCREW OUT OF THE BONE. DELAY OF 15 MINUTES AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9677431 ↗
• InjuryFeb 6, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING SURGERY DOCTOR PLACED TIBIA BONE PINS AND THE TISSUE PROTECTOR GOT STUCK ON THE PINS. BOTH PINS WERE IN, AND ONE WAS IN TOO FAR TO TAKE IT OUT USING THE DRILL. DOCTOR TRIED KNOCKING THE TISSUE PROTECTOR LOOSE WITH A MALLET BUT WAS UNSUCCESSFUL AND WAS ABLE TO GET ONE OF THE PINS OUT USING THE DRILL, AND THEN USED THE TISSUE PROTECTOR TO UNSCREW THE PIN OUT OF THE TIBIA. NO PATIENT INJURIES OR SURGICAL DELAYS REPORTED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9677408 ↗
• InjuryFeb 6, 2020Fracture; Mechanical Problem; Fracture; Mechanical Problem

  IT WAS REPORTED THAT DURING SURGERY SURGEON MADE TIBIAL INCISION FOR TRACKING ARRAY AND SCREWED IN FIRST TIBIAL BONE PIN. PLACED TISSUE PROTECTOR OVER BONE PIN AND SCREWED IN SECOND, BUT BROKE THE HEAD OF THE SECOND BONE PIN IN THE PROCESS. SURGEON REMOVED FIRST TIBIAL BONE PIN AND ATTEMPTED TO REMOVE TISSUE PROTECTOR FROM DAMAGED PIN WITH NO SUCCESS. TOOK PIN DRIVER OUT OF CHUCK AND CHUCKED DRILL DIRECTLY TO DAMAGED BONE PIN. SURGEON WAS ABLE TO REMOVE BROKEN BONE PIN FROM THE PATIENTS LEG; HOWEVER, EVEN WITH THE BONE PIN OUT OF THE LEG, THE BONE PIN COULD NOT BE REMOVED FROM THE TISSUE PROTECTOR. CASE WAS DELAYED AND SURGERY WAS COMPLETED WITH BACK-UP DEVICES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9677395 ↗
• InjuryFeb 6, 2020Break; Break

  IT WAS REPORTED THAT WHILE PLACING THE BONE SCREWS DOCTOR SCREWED IN ONE SCREW, PUT THE SOFT TISSUE PROTECTOR OVER THIS ONE AND THEN USED THE PROTECTOR TO SCREW IN THE SECOND. DOCTOR WAS UNABLE TO PULL THE SOFT TISSUE PROTECTOR OFF, HAD TO PUT AN OSTEOTOME THROUGH THE BRIDGED PART OF THE SOFT TISSUE PROTECTOR AND HIT UP WITH A MALLET TO GET IT OFF. IT HAPPENED ON BOTH THE FEMUR AND TIBIA. THE BONE SCREW DRIVER WAS USED TO PLACE ALL FOUR BONE SCREWS BUT WOULD NOT EASILY COME OFF AFTER THE SCREWS WERE SCREWED INTO PACE. DOCTOR HAD TO USE A MALLET AND HIT UP ON THE DRILL TO GET THE SCREW DRIVER OFF THE END OF THE SCREW. NO SURGICAL DELAYS REPORTED.

  Patient problems: Injury

  MAUDE report 9677387 ↗
• InjuryFeb 6, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE TISSUE PROTECTOR GOT STUCK ON THE BONE PIN WHILE PUTTING THE PINS IN THE TIBIA. BECAUSE THE TISSUE PROTECTOR WAS STUCK ON THE PIN AND THE PIN WAS IN THE LEG, THE ONLY WAY TO GET IT OFF WAS TO TRY AND REMOVE THE PIN AND THE PROTECTOR TOGETHER. THE SURGEON TRIED USING THE ALLEN T-WRENCH TO REMOVE THE BONE PIN AND THEN THE PIN BROKE. THEN DOCTOR TRIED USING MALLET TO REMOVE THE TISSUE PROTECTOR AND BONE PIN BY HITTING IT. WHILE DOING THIS, THE HANDLE OF THE TISSUE PROTECTOR BROKE OFF AND WAS EVENTUALLY ABLE TO GET THE PIN AND PROTECTOR OFF BY CONTINUING TO HIT IT. THEN HAD TO GO IN AND REMOVE THE PART OF THE PIN THAT BROKE OFF. AFTER ALL, IT WAS POSSIBLE TO PLACE ANOTHER BONE PIN OFF TO THE SIDE AND PROCEED WITH THE CASE. NO SURGICAL DELAYS CONFIRMED.

  Patient problems: Injury

  MAUDE report 9677383 ↗
• InjuryFeb 6, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING PROCEDURE TISSUE PROTECTOR GOT STUCK ON PINS. DELAY REPORTED BUT NO INFORMATION OF HOW LONG WAS THE SURGERY DELAYED. SCREWS WERE REMOVED FROM THE TISSUE PROTECTOR USING DRILL AND PIN DRIVER AS PRESCRIBED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9677376 ↗
• InjuryFeb 6, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING PROCEDURE THE BONE PINS BENT AND GOT STUCK IN THE SOFT TISSUE PROTECTOR. BONE PINS WERE TWISTED OUT AND RE DRILLED. NO PATIENT INJURIES OR DELAYS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9677263 ↗
• InjuryOct 24, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT TIBIAL BONE PIN GOT STUCK IN PRONG OF TISSUE PROTECTOR. COULD NOT REMOVE WITH MALLET AND IT WAS REMOVED WITH ANOTHER PIN DRIVER. DELAY OF LESS THAN 30 MINUTES REPORTED AND NO INJURIES INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9234518 ↗