NA 1806-0085SRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04546540195937), received between May 2, 2018 and Jul 22, 2025 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2025Break; Fracture; Material Deformation; Break; Fracture; Material Deformation

  THE CUSTOMER REPORTED THAT : "27-YEAR-OLD PATIENT ADMITTED TO THE EMERGENCY ROOM FOR INTRAMEDULLARY NAILING DUE TO A FRACTURE OF THE LEFT TIBIA. DURING THE REAMING PROCESS, THE GUIDE ROD BECAME DAMAGED AND BEGAN TO CHIP AWAY AT THE TIBIAL SHAFT." REMOVAL OF THE GUIDE ROD AND REPLACEMENT WITH A NEW ROD (DIFFERENT BATCH). NO CONSEQUENCES, NO METAL RESIDUE VISUALLY PRESENT IN THE SURGICAL SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22571004 ↗
• InjuryApr 29, 2025Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED THAT : "DURING REAMING FOR A FEMUR NAIL, THE NAIL GUIDE BROKE OFF SHARPLY AFTER FEW SECONDS OF REAMING. CLINICAL CONSEQUENCES AND CURRENT STATUS OF THE PATIENT OR PERSON INVOLVED: SERIOUS CONSEQUENCES, INCREASED DURATION OF INTERVENTION, ++ RISK OF INFECTION" 4/16/2025 - ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: THE PROCEDURE COULD BE COMPLETED CORRECTLY WITH ANOTHER GUIDE. MAJOR CONSEQUENCES FOR THE CHILD: LARGE ADDITIONAL INCISION (NEED FOR A LARGE ADDITIONAL SKIN INCISION TO REMOVE THE GUIDE), INCREASED BLOCK TIME, ++ RISK OF INFECTION.

  Patient problems: Insufficient Information

  MAUDE report 21924665 ↗
• InjuryJun 21, 2024Inaccurate Information; Inaccurate Information

  AS REPORTED: "FOLLOWING A SURGEON COMPLAINT OF A GUIDE WIRE OF INCORRECT LENGTH. SURGEON HAS SAID THE ATTACHED GUIDE WIRE WAS IN FACT NOT 1000MM AS STATED ON THE LABEL CAUSING A NEED TO CHANGE THE NAIL AND THUS INCREASING THE DURATION OF THE OPERATION."

  Patient problems: Insufficient Information

  MAUDE report 19582914 ↗
• MalfunctionJul 28, 2021Break; Break

  IT WAS REPORTED THE TIP OF THE K WIRE BROKE IN TWO PIECES; ONE PIECE WAS RETRIEVED, BUT THE SECOND PIECE WAS UNABLE TO BE REMOVED, AND REMAINED STUCK IN THE PATIENT'S BONE. THE REMAINING PIECE WAS LESS THAN 1CM IN LENGTH.

  Patient problems: Foreign Body In Patient

  MAUDE report 12237842 ↗
• MalfunctionJun 28, 2021Break

  TIP OF K WIRE BROKE IN 2 PCS, SMALL PIECE( LESS THAN 1 CM) STUCK IN PATIENT'S BONE, OTHER PIECE RETRIEVED. SURGEON UNABLE TO REMOVE PIECE OF K WIRE, DECIDED TO LEAVE IT IN THE BONE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12074726 ↗
• MalfunctionApr 22, 2020Fracture; Fracture

  THE CUSTOMER REPORTED THAT : "IT HAS BEEN NOTED THAT THE GUIDE WIRE HAS BROKEN IN ITS CENTER DURING THE OPERATION, REQUIRING EXTENSIVE WASHING AND CREATING AN EMBOLIC RISK. NO CLINICAL CONSEQUENCES HAVE BEEN REPORTED. THE INCRIMINATED DEVICE IS NOT AVAILABLE FOR EXPERTISE SINCE IT HAS BEEN THROWN AWAY. A MANDATORY REPORT HAS BEEN SENT TO THE ANSM."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9987094 ↗
• MalfunctionOct 23, 2019Appropriate Device Problem Term/Code Not Available

  A DOCTOR REPORTED THE FOLLOWING EVENT : "(B)(6) PATIENT, MANAGED FOR OSTEOSYNTHESIS BY CENTROMEDULLARY NAILING OF THE RIGHT TIBIA. DRILLING OF THE TIBIA AND INSERTION OF THE GUIDE ROD CENTERED IN THE FRONT AND PROFILE PIN, THEN IMPOSSIBILITY TO BRING OUT THE GUIDE ROD OF THE NAIL. " REMOVE THE NAIL WITH THE GUIDE ROD AND INSTALL A NEW NAIL. EXTENSION OF THE SURGICAL PROCEDURE. A SURGICAL DELAY WAS REPORTED; HOWEVER THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9226583 ↗
• InjuryMay 1, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INFECTION. THIS STERILE-PACKAGED GUIDE WIRE WAS USED DURING THE PRIMARY SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 8571243 ↗
• MalfunctionDec 1, 2018Device Contamination with Chemical or Other Material

  IN IN-COMING INSPECTION AT DISTRIBUTION, IT WAS FOUND THAT THERE WAS A FOREIGN MATERIAL (HAIR / BUG) IN BLISTER. THIS EVENT WAS FOUND ON 1 OF 50PCS OF 18060080S, LOT# K0B324F RECEIVED ON OUR (B)(4)AND 1 OF 100PCS OF 18060085S, LOT# K09A2F3 RECEIVED ON OUR (B)(4). NO PATIENT INVOLVEMENT, ADVERSE CONSEQUENCES, DELAY OR MEDICAL INTERVENTION.

  Patient problems: No Patient Involvement

  MAUDE report 8121785 ↗
• MalfunctionAug 2, 2018Break

  THE CUSTOMER REPORTED THAT A GUIDEWIRE BROKE INTRA-OPERATIVELY. THE ITEM BROKE OUTSIDE THE PATIENT AND NOTHING WAS LEFT INSIDE THE PATIENT. THE CUSTOMER FURTHER REPORTED THAT A SECOND GUIDEWIRE WORE THROUGH DURING THE SAME CASE. THE CUSTOMER WAS USING THE RIGID STRYKER GUIDEWIRE IN CONJUNCTION WITH A NON-STRYKER REAMER AND THE REAMER BROKE. THE STRYKER GUIDEWIRE REMAINS STUCK INSIDE THE NON-STRYKER REAMER AND WILL NOT BE COMING BACK TO STRYKER FOR INSPECTION. THERE WERE NO ADVERSE CONSEQUENCES ARISING FORM THE USE OF THE 2 STRYKER GUIDEWIRES. THERE WAS A SURGICAL DELAY BUT THE LENGTH OF THE DELAY WAS UNKNOWN ON INTAKE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7744878 ↗
• InjuryJun 18, 2018Appropriate Device Problem Term/Code Not Available

  THIS PI IS FOR THE GAMMA3 DRILL AND BALL-TIPPED GUIDE WIRE (TRAUMA & EXTREMITY DEVICES) THAT WAS USED ON THE PATIENT DURING PRIMARY SURGERY WHILE IMPLANTING A RIGHT HIP: IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED. "PATIENT HAD AN INFECTION AND HAD SOME COMPONENTS EXCHANGED DURING THE I AND D".

  Patient problems: Unspecified Infection

  MAUDE report 7612014 ↗
• MalfunctionMay 25, 2018Device Contamination with Chemical or Other Material; Packaging Problem

  THEATRE STAFF WENT TO OPEN A 1000 X 3MM GUIDE WIRE WHEN THEY NOTICED A BROWN DUST CONTAMINANT WITH THE OUTER PACKAGING END CAP. IT LOOKED LIKE IT COULD HAVE BEEN ATTRIBUTED TO WATER DAMAGE AND SO A DIFFERENT WIRE WAS OPENED.

  Patient problems: No Patient Involvement

  MAUDE report 7546056 ↗
• MalfunctionMay 2, 2018Fracture; Material Rupture

  THE PHARMACIST AT THE CLINIC, REPORTED THE FOLLOWING EVENT TO THE SALES REP : "RUPTURE OF THE GUIDE WIRE REF (B)(4) INTO THE REAMER SHAFT DIAM 8. THE GUIDE COULD NOT SLIDE AND FINALLY FRACTURED INTO THE SHAFT. IS IT A WEAR FAIL DOCTOR INDICATED THAT THE EVENT OCCURED DURING A TIBIAL NAILING. THERE WAS A DELAY IN THE PROCEDURE, INCREASE OF THE INFECTION RISK AND PEROPERATIVE FRACTURE. IT WAS NECESSARY TO CHANGE THE GUIDE AND TO REDUCE THE FRACTURE AGAIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7481133 ↗