NA 1210-6450SRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 04546540175366), received between Sep 4, 2015 and Feb 5, 2026 — classified as 4 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Fracture” (20 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Fracture

  AS REPORTED: "THE TIP BROKE OFF DURING FIXATION OF THE FEMORAL HEAD ROTATION AND REMAINED WITHIN THE BODY. ITS REMOVAL HAS BEEN CONFIRMED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270344 ↗
• InjurySep 3, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED BY THE CUSTOMER THAT DURING SURGERY, THE TIP OF A STRYKER K-WIRE SNAPPED OFF AND RETAINED IN PATIENT'S FEMORAL BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22950443 ↗
• InjuryAug 25, 2025Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED THE FOLLOWING: "DURING INSERTION OF THE PIN, THE THREADED PORTION BROKE IN THE FEMORAL HEAD. EXTRACTION OF THE PART WAS NOT PERFORMED, AND A PIECE OF PIN WAS LEFT IMPLANTED IN THE PATIENT. CLINICAL CONSEQUENCE AND CURRENT CONDITION OF THE PATIENT: NONE ACTIONS TAKEN FOR THE PATIENT REGARDING THE MD: PIN REPLACEMENT AND NO CONSEQUENCES FOR THE REST OF THE PROCEDURE." UPDATE (B)(6) 2025. "¿ WERE THERE ANY HARD BONES? INSERTION OF THE PIN INTO THE FEMORAL SHAFT AFTER BONE TREPANATION. ¿ HOW LONG WAS THE ITEM USED (APPROXIMATELY)? A FEW SECONDS/MINUTES, UNTIL THE TIP OF THE PIN BROKE OFF INSIDE THE FEMORAL HEAD."

  Patient problems: Foreign Body In Patient

  MAUDE report 22885591 ↗
• MalfunctionJun 4, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "TIP OF DEVICE SNAPPED OFF INSIDE PATIENT."

  Patient problems: Insufficient Information

  MAUDE report 22141783 ↗
• InjuryMar 3, 2025Off-Label Use; Off-Label Use

  AS REPORTED: "SURGEON BELIEVES THAT THE LAG SCREW REAMER COULD HAVE BEEN SKIVING DUE TO USING A GAMMA3 WIRE HAS SMALLER DIAMETER TO GAMMA4 WIRE. HE BELIEVES THIS COULD HAVE THEN REAMED OFF SOME OF THE SIDES OF THE NAIL IN THE LAG SCREW HOLE OF THE NAIL, WHICH COULD HAVE REDUCED THE STRENGTH OF THE NAIL." NAIL HAS NOW BROKEN AT LAG SCREW/NAIL INTERFACE. SURGEON SUGGESTS IT IS FROM IMPLANT FAILURE. SURGEON REMOVED AND REVISED CASE TO SYNTHES DHS. THIS EVENT IS CAPTURED UNDER MFR REPORT #0008031020-2025-00366.

  Patient problems: Pain

  MAUDE report 21510082 ↗
• MalfunctionFeb 12, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "AN EVENT TAKE PLACE YESTERDAY, IT WAS IN THE AGREEMENT OF THE CONSULTANT THEMSELVES THAT THE SITUATION WAS UNAVOIDABLE AND IT WAS A CLINICAL SITUATION FOR THE PATIENT. WE HAD A K WIRE BREAK BUT IT WAS DUE TO A PATHOLOGICAL NATURE WITHIN THE FEMUR BONE. THE PERSON HAD MULTIPLE SCLEROTIC REGIONS OF BONE AND THESE DENSE REGIONS WERE CAUSING DEFLECTIONS AND IT WAS COMPLETELY UNAVOIDABLE. HOWEVER, THERE WAS A BREAK OF A K-WIRE. IT WAS A GAMMA ANTEGRADE NAILING WITH A LONG NAIL AND IT WAS THE K WIRE ITSELF THAT WAS BROKEN DURING THE INSERTION OR IN PREPARATION FOR THE LAG SCREW. AND THE BASIS FOR IT WAS THE CLINICAL PRESENTATION OF MULTIPLE SCLEROTIC BONE WHICH WAS CAUSING DEFLECTIONS AND CHALLENGES IN GETTING THE CORRECT TRAJECTORY FOR THE TIP APEX DISTANCE. FURTHER DETAILS: THE PROCEDURE WAS COMPLETED SUCCESSFULLY THROUGH THE USE OF FURTHER K WIRES. CONSULTANT OPTED TO LEAVE BROKEN FRAGMENT OF K WIRE IN SITU AND PROGRESSED NORMALLY. ONLY ADVERSE EVENT IS A RETAINED FRAGMENT OF K WIRE IN THE NECK OF THE FEMUR. TIP APEX DISTANCE OF LAG SCREW WAS ACCEPTABLE GIVEN THE CIRCUMSTANCE BUT NOT IDEAL AS PER CONSULTANT FEEDBACK IT WAS UNAVOIDABLE."

  Patient problems: Foreign Body In Patient

  MAUDE report 18691083 ↗
• MalfunctionJul 5, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "DURING INSERTION A K-WIRE, APPROXIMATELY 10 MM OF THE TIP OF THE K-WIRE WAS BROKEN OFF IN THE BONE HEAD, RESULTING IN THE TIP WAS LEFT IN THE PATIENT. A SURGICAL DELAY OF 10 MINUTES WAS REPORTED."

  Patient problems: Foreign Body In Patient

  MAUDE report 17257106 ↗
• InjuryMay 16, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "FIRST SURGERY WAS PERFORMED IN HOSPITAL SANDE (B)(6). THE TIP OF THE K-WIRE BROKE OFF. THIS WAS NOT REMOVED IN SANDE. ACCORDING TO THE SURGEON, THE PATIENT WAS IN PAIN. THE TIP WAS REMOVED ARTHROSCOPICALLY IN HOSPITAL EV OLDENBURG (SURGERY TIME 1 HOUR). THIS WAS ON (B)(6) 2023. X-RAY IMAGES ARE AVAILABLE! ITEM WAS DISPOSED BY CUSTOMER AFTER REVISION.

  Patient problems: Foreign Body In Patient; Implant Pain

  MAUDE report 16942861 ↗
• MalfunctionApr 6, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT "DURING A FEMORAL NAILING PROCEDURE, WHEN THE SURGEON USED THE WIRE TO PREPARE THE CERVICAL SCREW, THE TIP OF THE WIRE BROKE OFF, LEAVING A FRAGMENT OF LESS THAN A CENTIMETER IN THE PATIENT. UPON REMOVAL OF THE WIRE WE FOUND THAT A PIECE OF THE WIRE WAS MISSING AND REMAINED IN THE PATIENT. CONFIRMED BY THE INTRAOPERATIVE X-RAY".

  Patient problems: Foreign Body In Patient

  MAUDE report 16694463 ↗
• MalfunctionFeb 24, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "PATIENT TAKEN TO THE OPERATING ROOM FOR A TROCHANTERIC NAIL PLACEMENT. ONCE THE NAIL IS IN PLACE, THE GUIDE PIN IS INSERTED. INSERTION PROVED TO BE A DELICATE OPERATION. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, THE SURGEON REALIZED THAT THE GUIDE WIRE HAD BROKEN IN THE FEMORAL HEAD. CONSEQUENCE: DIFFICULT TO EXTRACT, IT WAS NECESSARY TO REMOVE THE PREVIOUSLY PLACED NAIL, TO BRING OUT ADDITIONAL MATERIAL AND CONSUMABLES ADDITIONAL MATERIAL, ADDITIONAL CONSUMABLES: INCREASE IN THE DURATION OF THE OPERATION, AND ITS THE DURATION OF THE OPERATION, AND ITS COST."

  Patient problems: Insufficient Information

  MAUDE report 16435294 ↗
• MalfunctionDec 2, 2022Component Missing; Component Missing

  AS REPORTED: "DURING THE PROCEDURE, THE NURSE OPENED THE BOX FOR A SPINDLE WHICH WAS EMPTY. THEY OPENED ANOTHER BOX TO COMPLETE THE PROCEDURE". THERE WAS AN SURGICAL DELAY OF UNKNOWN LENGTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15911528 ↗
• MalfunctionOct 26, 2022Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED THAT: "PROCEDURE: OSTEOSYNTHESIS FOR FEMORAL NECK FRACTURE - PLACEMENT OF GAMMA LONG NAIL. DURING THE OPERATION, AT THE TIME OF THE AIMING FOR THE CERVICAL SCREW, USE OF A THREADED KIRCHNER WIRE. SEVERAL SIGHTS ARE PERFORMED UNDER X-RAY CONTROL IN FRONT AND IN PROFILE. DURING THE OPERATION, THE SMOOTH PART AND THE THREADED PART BROKE, THE DISTAL TIP WAS FOUND IN THE NAIL EYELET. CONSEQUENCE(S) OF THE ADVERSE EVENT : INCREASE IN THE DURATION OF THE PROCEDURE. RADIATION EXPOSURE ++ FOR THE OPERATING TEAM AND THE PATIENT. RECOVERY ACTION(S) TAKEN: RECOVERY OF THE THREADED TIP UNDER X-RAY WITH A LONG INSTRUMENT. USE OF A NEW WIRE AND COMPLETION OF THE PROCEDURE."

  Patient problems: Unintended Radiation Exposure

  MAUDE report 15672664 ↗
• MalfunctionApr 22, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "DURING SURGERY ONE OF THE K-WIRES BEING USED REF. (B)(4), LOT: K04043F, EXP, 2626-06-20 BROKE OFF AND LODGED INTO THE LEFT HIP BONE. SURGEON WAS UNABLE TO RETRIEVE THE BROKEN PIECE."

  Patient problems: Foreign Body In Patient

  MAUDE report 14186347 ↗
• MalfunctionNov 15, 2021Break; Fracture; Break; Fracture

  CUSTOMER REPORTED THE FOLLOWING ISSUE: "INTERVENTION FOR A LONG GAMMA NAIL. WHEN USING THE KIRSHNER WIRE, THE END OF THE WIRE BROKE OFF IN THE NAIL. THE NAIL HAD TO BE REMOVED, THE BROKEN END HAD TO BE REMOVED AND THEN A NEW WIRE HAD TO BE USED. THIS LED TO AN EXTENSION OF THE INTERVENTION (3 MINUTES OF DELAY)".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12810739 ↗
• MalfunctionNov 10, 2021Fracture; Fracture

  THE CUSTOMER REPORTED THE FOLLOWING EVENT UNDER MEDWATCH MW5104392: "DURING A LEFT FEMORAL TROCHANTERIC NAILING THE FIRST GUIDEWIRE USED THE TIP OF THE GUIDEWIRE BROKE IN THE INTRAMEDULLARY CANAL OF FEMUR. AT THIS TIME IT WAS NOTED THAT LEAVING THE BROKEN METAL TIP IN THE BONE AS SUPPOSE TO ATTEMPTING TO REMOVE IT WOULD BE LESS DAMAGING TO THE PATIENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 12790813 ↗
• MalfunctionOct 12, 2021Fracture; Fracture

  AS REPORTED: "THE PATIENT WAS TAKEN TO SURGERY ON (B)(6) 2021 FOR A LEFT FEMORAL TROCHANTERIC NAILING WITH GAMMA NAIL, WITH NERVE BLOCK AND UNDER FLUOROSCOPY. DURING THE PASSING OF THE FIRST GUIDEWIRE, THE TIP OF THE GUIDEWIRE BROKE IN THE INTRAMEDULLARY CANAL OF THE FEMUR. AT THIS TIME, IT WAS NOTED THAT LEAVING THE BROKEN METAL TIP IN THE BONE, AS OPPOSED TO REMOVING IT, WOULD BE LESS DAMAGING TO THE PATIENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 12615346 ↗
• MalfunctionJun 4, 2021Break; Break

  IT WAS REPORTED THAT THE SURGEON WAS OVER REAMING FOR THE PROXIMAL SCREW PLACEMENT WHEN THE THREADED GUIDE PIN BROKE (CAT# 1210-645S). THE THREADS GOT STUCK IN THE SOFT TISSUE AND COULD NOT BE RETRIEVED. THE TIP OF THE GUIDE WIRE LEFT IN THE PATIENT IS APPROXIMATELY 3MM. THE PATIENT HAD A GAMMA NAIL THAT WAS A NON-UNION; THE GAMMA NAIL WAS NOT REMOVED. THE SURGERY WAS A REPAIR OF NON-UNION RIGHT HIP.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 11942589 ↗
• MalfunctionJan 18, 2021Fracture; Fracture

  AS REPORTED: "I WAS MADE AWARE TODAY THAT THE TIP OF A GAMMA GUIDE WIRE ITEM # 1210-6450S (LOT# K0E3549) BROKE OFF INSIDE THE GREATER TROCH REGION WHILE THEY WERE ATTEMPTING TO GET THE STARTING POINT FOR AN ALPHA GT NAIL ON (B)(6) 2020. THEY DECLINED TO REMOVE THE TIP OF THE WIRE BECAUSE IT WOULD HAVE CAUSED MORE DAMAGE TO DO SO. THE PROCEDURE CONTINUED AND WAS COMPLETED WITHOUT FURTHER ISSUE OR SURGICAL DELAY."

  Patient problems: Foreign Body In Patient

  MAUDE report 11189697 ↗
• MalfunctionJul 30, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A RIGHT HIP REVISION, THE TIPS OF 2 K-WIRES BROKE OFF IN THE PATIENT'S BONE. THE TIPS WERE RETRIEVED OUT OF THE PATIENT. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. ADDITIONAL INFORMATION: "THEY USED THE K-WIRE TO REAM OVER WITH A GREY REVISION END MILL. THE TIP OF BOTH GUIDE WIRES BROKE. THE BROKEN TIPS WERE RETRIEVED WITHOUT INCIDENT."

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

  MAUDE report 10347527 ↗
• MalfunctionJul 30, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A RIGHT HIP REVISION, THE TIPS OF 2 K-WIRES BROKE OFF IN THE PATIENT'S BONE. THE TIPS WERE RETRIEVED OUT OF THE PATIENT. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. ADDITIONAL INFORMATION: "THEY USED THE K-WIRE TO REAM OVER WITH A GREY REVISION END MILL. THE TIP OF BOTH GUIDE WIRES BROKE. THE BROKEN TIPS WERE RETRIEVED WITHOUT INCIDENT."

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

  MAUDE report 10347451 ↗
• MalfunctionJun 10, 2020Fracture; Fracture

  AS REPORTED: GAMMA 3.2MM X 450 K-WIRE, THREADED TIP OF WIRE SEPARATED FROM REST OF WIRE ON INSERTION INTO GREAT TROCHANTER. SURGEON WAS USING K-WIRE THROUGH THE CANNULATED AWL, TIP BROKE ON 3RD PASS THROUGH THE AWL. PATIENT WITH METASTATIC LEGIONS IN GT, SURGEON REPORTED THAT ¿IT DIDN¿T FEEL AS THOUGH THE WIRE WAS GOING THROUGH ANY PARTICULARLY DENSE BONE DURING THE 3 PASSES. BROKEN THREADED TIP OF K-WIRE LEFT IN-SITU, PROCEDURE CONTINUED WITHOUT ANY IMPACT. ADDITIONALLY REPORTED: APPROXIMATE 2-3 MINUTE DELAY TO PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10140827 ↗
• MalfunctionMay 1, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS REPORTED, OPENED A K-WIRE AND THERE WAS A HAIR FOUND IN THE STERILE PACKAGING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10019191 ↗
• MalfunctionDec 23, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED, DURING AN IN-COMING INSPECTION AT DISTRIBUTION, IT WAS FOUND THAT THERE WAS A FOREIGN MATERIAL (HAIR) IN BLISTER PACKAGE. THIS EVENT WAS FOUND ON 1 OF 100 UNITS WITH LOT#K09859C.

  Patient problems: No Patient Involvement

  MAUDE report 9513690 ↗
• MalfunctionOct 30, 2019Break; Fracture; Fracture

  DURING AN ORTHOPEDIC SURGERY, A GUIDE/BLOCKING PIN PIECE BROKE OFF; COULD NOT BE REMOVED, AND THE BROKEN PIECE WAS LEFT IN THE PATIENT. SURGEON INDICATED THAT THERE ARE MORE RISK TO ATTEMPT TO REMOVE.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 9257691 ↗
• MalfunctionOct 30, 2019Break; Fracture; Fracture

  DURING AN ORTHOPEDIC SURGERY, A GUIDE/BLOCKING PIN PIECE BROKE OFF; COULD NOT BE REMOVED, AND THE BROKEN PIECE WAS LEFT IN THE PATIENT. SURGEON INDICATED THAT THERE ARE MORE RISK TO ATTEMPT TO REMOVE.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 9257689 ↗