Truliant 02-029-90-4100Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885862585882), received between Dec 4, 2020 and Oct 11, 2022 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2022Break; Break

  AS REPORTED, A TIBIA PIN PULLER WAS NOTICED SITTING IN AN EXTRA PAIN THAT IS KEPT IN STERILE PROCESSING. IT IS A TIBIA PIN PULLER THAT HAD A PRONG FROM THE TIP BREAK OFF IN THE PAST. THE DATE/CASE THIS HAPPENED IS UNKNOWN. NO OTHER INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15583600 ↗
• MalfunctionAug 18, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT DURING A PROCEDURE, A PIECE FROM THE PIN PULLER FELL INTO THE WOUND SITE AND WAS IMMEDIATELY REMOVED BY THE SURGEON. THERE WAS NO SURGICAL DELAY. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE PRODUCT IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15254746 ↗
• MalfunctionJun 26, 2022Break; Break

  AS REPORTED, DURING SURGICAL REMOVAL OF THE TIBIAL HEADED PINS FOR THE TRULIANT TIBIA TRIAL TRAY, USING THE PIN PULLER, ONE OF THE DISTAL PRONGS OF THE PIN PULLER BROKE. THE PRONG OF THE PIN PULLER ONCE IT BROKE OFF FELL WITHIN THE WOUND ONTO THE TIBIA TRAY. THE BROKEN PRONG PIECE WAS REMOVED FROM THE WOUND AND THE PATIENT. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICE WILL BE RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14823416 ↗
• InjuryJan 24, 2022Break; Break

  AS REPORTED, DURING SURGICAL USE THE TRULIANT PIN PULLER BROKE DURING A TRULIANT TKA. THE PIN PULLER WAS ENGAGED WITH THE PIN AND UPON PULLING THE PIN VERTICALLY UP OUT OF THE TIBIA TRAY THE PIN PULLER INNER PRONG BROKE. THE BROKEN PRONG WAS ISOLATED AND REMOVED FROM THE STERILE FIELD. THERE WERE NO PARTS OR PIECES OF THE DEVICE FELL INTO THE PATIENT WOUND SITE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE PIN PULLER IS NOT USABLE AND IS BEING RETURNED TO EXACTECH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13338207 ↗
• MalfunctionDec 14, 2021Break; Break

  AS REPORTED, DURING SURGICAL USE, THIS INSTRUMENT BROKE WHEN THE SURGEON WAS REMOVING THE HEADED PINS FROM THE TIBIA. THERE WAS NO PARTS OR PIECES OF THE DEVICE FELL INTO THE PATIENT WOUND SITE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13003271 ↗
• MalfunctionNov 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING SURGICAL USE, SURGEON WAS PLACING A TIBIA PIN INTO THE TRAY WHEN THE SMALL SILVER PIN GRABBERS BROKE. IMMEDIATELY THE PIN PULLER PIECES WERE REMOVED, AND A NEW PIN PULLER WAS OPENED FOR THEM TO CONTINUE SURGERY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857959 ↗
• MalfunctionAug 6, 2021Break; Break

  AS REPORTED, THE PIN PULLER (CAT# 02-029-90-4100) WAS USED TO REMOVE THE PINS OUT OF THE TIBIA. THE BONE QUALITY WAS VERY GOOD AND WHEN THE SURGEON TRIED TO REMOVE THE PIN, THE TIP OF THE PIN PULLER BROKE OFF. FURTHERMORE, THE FEM IMPACTOR (02-029-19-1000) WAS BROKEN ON IMPACTION WHEN WE WERE IMPACTING THE FINAL FEMUR IMPLANT ON. ONE OF THE SIDES OF THE IMPACTOR BROKE OFF. THE SURGERY WAS NOT AFFECTED BY THE BREAKAGE. WE HAD BACKUPS AND THE CASE WENT VERY WELL. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12287891 ↗
• MalfunctionMay 3, 2021Break; Break

  AS REPORTED, THE NEWLY DESIGNED TRULIANT TIBIA-HEADED PIN PULLERS ARE FINICKY WHEN INSERTING AND REMOVING THE HEADED PINS FOR THE TIBIA TRAIL TRAY. WHEN USING THE PIN PULLER TO PUSH THE PIN INTO THE TRIAL TRAY TO SECURE IT TO THE BONE THE PRONGS THAT EXPANDED AND RETRACT TO GRAB THE PIN GET CAUGHT OR STUCK WITHIN THE TIBIA TRAIL TRAY HOLE. THE PRONGS DO NOT EXPAND OPEN FAR ENOUGH TO LET GO OF THE PIN BEFORE THE PRONGS HIT THE TIBIA TRIAL TRAY HOLE WALL. IT THEN DOES NOT ALLOW THE SURGEON TO LEAVE THE PIN IN. THE SURGEON HAS TO REMOVE THE PIN OR BACK THE PINOUT TO BE ABLE TO RELEASE THE PIN FULLY AND THEN A TAMP OF SOME SORT IS NEEDED TO TAMP THE PIN IN THE REST OF THE WAY. THE PIN PULLER WILL ALSO NOT WORK TO REMOVE THE PIN ONCE IT IS SEATED ALL THE WAY DOWN. THE PRONGS DO NOT OPEN UP WIDE ENOUGH TO GET AROUND THE PIN WITHIN THE TIBIA TRIAL HOLE. THIS CAUSES THE SURGEON TO STRUGGLE AND ADDS EXTRA TIME TO THE PROCEDURE. VIDEOS WERE TAKEN IN SURGERY AND SENT TO THE PRODUCT SPECIALISTS AND ENGINEERS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION DUE TO PRODUCT IS NEEDED FOR SURGICAL USE UNTIL ANOTHER SOLUTION IS SENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11761295 ↗
• MalfunctionApr 6, 2021Break; Break

  AS REPORTED, THE TRULIANT TIBIA PIN PULLER HAD A PRONG BREAK-OFF WHEN A HEADED PIN WAS TRYING TO BE REMOVED FROM THE BONE WITHIN THE TRIAL TIBIA TRAY. THE SURGEON WAS ABLE TO GET THE PIN OUT OF THE BONE USING A BACKUP PIN PULLER THAT WAS PEEL PACKED. THERE WAS NO DELAY IN THE SURGERY. THE PATIENT LEFT THE OR STABLE. THERE WERE NO PIECES LEFT IN THE PATIENT. THE BROKEN PIN PULLER AND THE BROKEN PRONG WERE LOCATED, IDENTIFIED, AND ISOLATED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS AVAILABLE FOR RETURN TO THE COMPANY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11625219 ↗
• MalfunctionDec 22, 2020Break; Break

  AS REPORTED, DURING AN INITIAL TKA PROCEDURE ON A MALE PATIENT, DURING USE OF THE TRULIANT TIBIA PIN PULLER TO INSERT HEADED PINS INTO THE TRIAL TIBIA TRAY THE PA NOTICED THAT ONE OF THE PRONGS ON THE PIN PULLER WAS BROKEN OFF. THE BROKEN PIECE OF THE PIN PULLER WAS FOUND AND CONTAINED. THERE WERE NO PIECES LEFT IN THE PATIENT. A SECOND TIBIA PREP PAN WAS OPENED TO THE FIELD TO OBTAIN A NEW PIN PULLER TO REMOVE THE PINS FROM THE BONE. THE BROKEN PIN PULLER IS BEING RETURNED. THE PRONG OF THE PIN PULLER FELL ONTO THE TIBIA TRIAL AND THE PA WAS ABLE TO GRAB IT, AND CONTAIN IT ON THE BACK TABLE. THE PATIENT LEFT THE OR STABLE. THE STAFF TOOK A COUPLE OF MINUTES TO LOOK FOR THE BROKEN PIECE OF THE PRONG WHILE WAITING FOR ME TO GRAB A NEW TIBIA PREP PAN TO GET A NEW PIN PULLER FOR REMOVAL OF PINS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11061039 ↗
• InjuryDec 4, 2020Break; Break

  WHEN RE-SETTING TRAYS IN SPD AFTER SURGERY I ALWAYS CHECK THE INSTRUMENTS TO MAKE SURE THEY ARE CLEAN AND FUNCTIONING AS EXPECTED. WHEN CHECKING THE TRULIANT TIBIA PIN PULLER I NOTICED THAT ONE OF THE PRONGS WAS BROKEN OFF. THE BROKEN PIN PULLER WILL BE SENT BACK TO EXACETCH. FOUND IN SPD WHEN CLEANING UP/RESETTING TRAYS AFTER SURGERY. ADDITIONAL INFORMATION RECEIVED FROM REP: I AM UNSURE WHAT PATIENT OR CASE THIS HAPPENED FROM AS THERE WAS MULTIPLE KNEES THAT DAY AND SPD DOES NOT CATEGORIZE WASHED PANS BY WHEN EACH CASE WAS. I WILL CHECK POST OP X-RAYS. THE PRONG WAS NOT SEEN WITH THE INSTRUMENTS ON SPD. IT WASN¿T FOUND.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10946346 ↗