NA 1806-6170Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540510068), received between Feb 5, 2019 and Jan 2, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "THE HEAD OF THE END CAP SLIPPED DURING REMOVAL, CAUSING REMOVAL DIFFICULTY. THE END CAP WAS LOCKED TIGHTLY AND THE TIP OF THE SCREWDRIVER WAS DEFORMED. THE REVERSE THREADED SCREWDRIVER OF THE REMOVAL INSTRUMENT WAS ALSO BROKEN. OTHER INSTRUMENTS USED WERE ALSO DAMAGED. FINALLY THE END CAP AND OTHER IMPLANTS WERE REMOVED FROM THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18425680 ↗
• MalfunctionAug 9, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "IT APPEARS THAT THE INSTRUMENT BROKE DURING THE EXTRACTION PROCEDURE." THE EXTRACTION WAS A PLANNED REMOVAL DUE TO COMPLETED BONE UNION AND ALL DEBRIS WAS REMOVED FROM THE SURGICAL FIELD/PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17487657 ↗
• InjuryApr 28, 2023Break; Fracture; Off-Label Use; Break; Fracture; Off-Label Use

  AS REPORTED: "USED TIMEX EXTRACTION KIT FOR PROXIMAL HUMERAL NAIL REMOVAL. THE NAIL WOULD NOT COME OUT USING THE USUAL CONICAL EXTRACTOR. THE MALE EXTRACTOR 4MM WAS USED TO TRY CLEAR BONE INSIDE THE NAIL AND BROKE WHILST TRYING TO EXTRACT NAIL. THE BROKEN PART REMAINS IN THE NAIL. UNABLE TO EXTRACT NAIL AND HAD TO LEAVE THE NAIL IN PATIENT. NB: THE MALE EXTRACTOR WOULD NOT USUALLY BE USED IN THIS SITUATION HOWEVER NOTHING ELSE WAS WORKING THEREFORE IT WAS ATTEMPTED TO FORCE THE NAIL OUT IN OTHER WAYS. THE PATIENT HAD ALREADY BEEN ON THE TABLE FOR APPROXIMATELY 2 HOURS TRYING TO EXTRACT THE NAIL BEFORE THE MALE EXTRACTOR BROKE." ADDITIONAL INFORMATION: THE PATIENT WANTED IT REMOVED AS THEY HAD DISCOMFORT WHEN RAISING THEIR ARMS UP, IT WAS THOUGHT THE NAIL WAS NOT BURIED ENOUGH HOWEVER ONCE OPENED, THE TOP OF THE NAIL WAS FIRMLY BURIED BENEATH BONE. IT WAS A PLANNED REMOVAL DUE TO PATIENT DISCOMFORT AND THE SURGEON IS NOT PLANNING TO MAKE ANOTHER ATTEMPT TO REMOVE THE NAIL.

  Patient problems: Foreign Body In Patient

  MAUDE report 16832221 ↗
• InjuryDec 28, 2020Fracture; Fracture

  THE CUSTOMER REPORTED TO THE SALES REP THAT: "DURING MY LAST INTERVENTION OF THE DAY, I HAD TO TRY TO REMOVE SOME OLD SCREWS FROM A FOOT. DURING THIS ATTEMPT, I FIRST USED THE APPROPRIATE SCREWDRIVER, BUT UNFORTUNATELY THE THREAD DID NOT HOLD AND THIS DAMAGED THE THREAD, MAKING IT IMPOSSIBLE TO REMOVE THEM. I THEN ASKED FOR THE UNIVERSAL EXTRACTION TOOL. THIS TIME I WAS ABLE TO GET A GRIP, BUT THE HARDWARE BROKE. I USED THE SIZE ABOVE, BUT AGAIN THE MATERIAL BROKE. SO I HAD TO CUT THE BONE AROUND THE TREFFIN SCREWS, WHICH MADE THE OPERATION VERY COMPLICATED AND THE RESULT VERY UNCERTAIN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11076932 ↗
• MalfunctionSep 30, 2020Fracture; Fracture

  AS REPORTED: "WHILE ATTEMPTING TO REMOVE A SCREW FROM AN OLD LISS PLATE ALONG THE LATERAL PORTION OF THE FEMUR, THE DOCTOR REALIZED THAT THE HEAD OF THE SCREW WAS STRIPPED. WE ATTEMPTED TO USE A CONICAL MALE EXTRACTOR, 2.5MM TO REMOVE THE STUCK SCREW. WHILE ATTEMPTING TO TORQUE THE CONICAL EXTRACTOR IN PLACE, THE TIP OF THE EXTRACTOR BROKE OFF INSIDE OF THE SCREW. AFTER SEVERAL ATTEMPTS THE DOCTOR DETERMINED WE CAN PROCEED WITH THE PROCEDURE WITHOUT THAT SCREW REMOVED AND LEFT IT IN PLACE, WHILE ALSO LEAVING THE BROKEN TIP OF THE EXTRACTOR AS WELL." THIS WAS A PRIMARY KNEE AND THE SCREWS NEEDED TO BE REMOVED IN ORDER TO USE THE IM ROD FOR THE DISTAL FEMORAL CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10608456 ↗
• MalfunctionFeb 5, 2019Break; Entrapment of Device

  PATIENT CAME IN WITH A MIDSHAFT FEMUR FRACTURE. THE PATIENT ALREADY HAD AN OLD COMPETITOR HIP SCREW FROM AN UNKNOWN DATE. USING THE STRYKER EXTRACTION SETS, SURGEON TRIED A FEW OPTIONS TO TAKE THE COMPETITOR DEVICE OUT BUT COULD NOT GET IT OUT. A LAST RESORT OPTION HE TRIED THE CONICAL EXTRACTOR (B)(4), THE EXTRACTOR BECAME TIGHT AND THEN BOKE 3/4 THE WAY UP THE THREADS. FROM THAT POINT THE END OF THE EXTRACTOR WAS STUCK IN THE COMPETITOR DEVICE WHICH IS STILL IN THE PATIENT. SURGEON DECIDED TO THEN PLATE THE FEMUR INSTEAD OF REMOVING THE HARDWARE AND NAILING IT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8304868 ↗