NA 2351-0030Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07613327361674), received between Jun 25, 2019 and Nov 12, 2024 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 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.

• MalfunctionNov 12, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "BROKEN INSTRUMENT." NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20665418 ↗
• MalfunctionAug 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED: "BOLT ON THE INSTRUMENT IS BROKEN OR HAS COME OFF. BOLT ON THE INSTRUMENT CAN NO LONGER BE USED OR CAN ONLY BE USED TO A LIMITED EXTENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20026356 ↗
• MalfunctionJan 3, 2024Break; Fracture; Detachment of Device or Device Component; Break; Fracture; Detachment of Device or Device Component

  AS REPORTED: "GUIDE WIRE HANDLE BROKE ONE "SCREW" OF HANDLE FELL OUT AND RENDERED HANDLE UNUSABLE. ANOTHER TRAY HAD TO BE OPENED TO COMPLETE THE CASE. THERE WAS A 5 MIN SURGICAL DELAY. WASHED BY HOSPITAL SPD AFTER CASE." ALL DEBRIS WAS REMOVED FROM THE SURGICAL FIELD/PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18438060 ↗
• MalfunctionNov 13, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "OUR GUIDE WIRE HANDLE IN OUR CONSIGNED IM NAILING BASIC TRAY IS BROKEN. IT IS NOT GRABBING THE WIRE LIKE IT SHOULD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18123375 ↗
• MalfunctionAug 30, 2023Component Missing; Component Missing

  AS REPORTED: "DURING SURGERY AN INSTRUMENT (GUIDE WIRE HANDLE) WAS FOUND TO BE UNUSABLE AS IT WAS FOUND TO MISSING A PART. IT WAS NECESSARY TO OPEN AN ADDITIONAL SET TO USE THE HANDLE FROM THAT SET TO FINISH THE SURGERY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17657901 ↗
• MalfunctionAug 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: "DURING PREPARATION OF THE HANDLE FOR THE GUIDE WIRE (T2 ALPHA SYSTEM), A SMALL BOLT GOT LOST."

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17476018 ↗
• MalfunctionJul 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: "DURING A LEFT FEMORAL NAIL PROCEDURE, UPON IMPACTION, 2 SCREWS DISLODGED FROM THE GUIDE WIRE HANDLE. ALL PARTS WERE RETRIEVED, NOTHING LEFT IN THE PATIENT. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 1-2 MINUTES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375836 ↗
• MalfunctionApr 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: "AFTER SURGERY THE SMALL "SCREWS"/ RIVET FELL OUT OF THE T2 ALPHA HANDLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16774964 ↗
• MalfunctionNov 29, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "THE CUSTOMER WAS USING THE GUIDEWIRE HANDLE, AND HITTING ON IT. SUDDENLY IT BREAKS, AND CAN NOT BE USED ANYMORE." THE SURGEON NEEDED A NEW GUIDE WIRE HANDLE, SO THEY HAD TO FIND A NEW ONE IN ANOTHER KIT FROM ANOTHER SUPPLIER. APPROX. 15 MIN. DELAY. ALL DEBRIS WAS REMOVED. THE HANDLE BROKE IN TWO. CLEAN CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15883339 ↗
• MalfunctionDec 8, 2020Fracture; Fracture

  AS REPORTED: "WHEN USING THE GUIDE WIRE HANDLE TO INSERT THE 3.2 X 1000 GUIDE WIRE INTO THE IM CANAL OF THE FEMUR, THE DOCTOR WAS USING THE MALLET TO INSERT THE GUIDE WIRE. WHEN IMPACTING THE GUIDE WIRE THE PIVOT POST THAT HOLDS THE HANDLE TOGETHER BROKE. ALL PIECES WERE RECOVERED AND THERE WERE NO COMPLICATIONS WITH THE CASE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10967836 ↗
• MalfunctionNov 13, 2020Fracture; Fracture

  WHEN USING THE GUIDE WIRE HANDLE TO INSERT THE 3.2 X 1000 GUIDE WIRE INTO THE IM CANAL OF THE FEMUR, THE DOCTOR WAS USING THE MALLET TO INSERT THE GUIDE WIRE. WHEN IMPACTING THE GUIDE WIRE THE PIVOT POST THAT HOLDS THE HANDLE TOGETHER BROKE. ALL PIECES WERE RECOVERED AND THERE WERE NO COMPLICATIONS WITH THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10838654 ↗
• MalfunctionSep 30, 2020Component Missing; Component Missing

  GUIDE WIRE HANDLE HAS A MISSING PIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10609068 ↗
• MalfunctionSep 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: "PRIMARY PROCEDURE, LEFT TIBIAL NAIL. IT WAS REPORTED THAT UPON IMPACTION, A SMALL PIECE (POSSIBLY A NUT) FELL OFF OF THE GUIDE WIRE HANDLE. THE PIECE DID NOT FALL INTO THE PATIENT. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO SURGICAL DELAY. REP CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10576721 ↗
• MalfunctionAug 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: DURING A T2 ALPHA TIBIAL NAIL CASE AT ROYAL PERTH HOSPITAL THE SCRUB NURSE NOTICED ONE OF THE STEEL METAL PLUGS HAD FALLEN OUT FROM THE GUIDE WIRE HANDLE. THE GUIDE WIRE HANDLE WAS NOT NEEDED FOR THE REST OF THE CASE. WITH THE METAL PLUG FALLING OUT IT MADE THE GUIDE WIRE HANDLE UNUSABLE AS IT DIDN'T RETAIN WIRES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10380014 ↗
• MalfunctionFeb 7, 2020Component Missing; Detachment of Device or Device Component; Component Missing; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT AS HE WAS USING THE T2 ALPHA BASIC GUIDE WIRE HANDLE HE NOTICED THAT THERE WERE SCREWS MISSING FROM THE HANDLE. THE SURGEON BELIEVES THAT THE DEVICE WAS RETURNED FROM RE-PROCESSING WITH THE SCREWS MISSING. THERE IS NO UNINTENDED METAL IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9684865 ↗
• MalfunctionFeb 5, 2020Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGEON WAS HITTING THE GUIDE WIRE HANDLE AND THE HANDLE BROKE. APPARENTLY THE PIECES FLEW ACROSS THE ROOM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9674103 ↗
• MalfunctionDec 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE STRYKER SALES REPRESENTATIVE REPORTED THAT DURING THE CASE, THE SCREW CAME OUT OF THE T2 ALPHA GUIDE WIRE HANDLE. THE SILVER BOLT CAME OUT INTO THE INCISION. THE SURGEON WAS ABLE TO LOCATE THE ITEM BUT THIS RESULTED IN A SURGICAL DELAY. THE SURGEON WAS NOT USING EXCESSIVE FORCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9511482 ↗
• MalfunctionJun 25, 2019Disconnection; Disconnection; Device Slipped

  SURGEON WAS USING THE T2 ALPHA GUIDE WIRE GRIPPER, WHILST USING IT A SMALL SCREW FELL OUT. THERE WAS A SLIGHT DELAY OF 5 MINUTES IN THE PROCEDURE AS THE STAFF FETCHED ANOTHER GUIDE WIRE HANDLE. STRYKER REP REPORTED THAT THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8732805 ↗