NA 702496Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04546540112415), received between Jul 16, 2018 and Mar 24, 2026 — classified as 5 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (18 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Fracture

  IT WAS REPORTED THAT WHEN EXTRACTING THE ASNIS, THE SCREW HEAD BECAME STRIPPED DUE TO BONE QUALITY ISSUES. AN ATTEMPT WAS MADE TO REMOVE IT USING AN EXTRACTOR, BUT BOTH THE SCREW AND THE EXTRACTOR FRACTURED. THE FRACTURED TIP OF THE SCREW COULD NOT BE REMOVED AND WAS LEFT IN PLACE, CONCLUDING THE OPERATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 24682447 ↗
• InjuryJan 20, 2026Fracture

  IT WAS REPORTED THAT DURING THE EXTRACTION OF ASNIS 4.0, THE EXTRACTION PROVED DIFFICULT DUE TO THE BONE QUALITY BEING FAVOURABLE. UPON USING THE EXTRACTOR, THE TIP OF THE EXTRACTOR BROKE OFF. THE ASINIS 4.0 COULD NOT BE REMOVED AND REMAINS IMPLANTED IN THE BODY. IT IS NOTED THAT FRAGMENTS REMAIN WITHIN THE BODY. THE PHYSICIAN BELIEVES THESE FRAGMENTS CAN BE REMOVED DURING THE ATTEMPTED RE-EXTRACTION OF THE ASNIS.

  Patient problems: Foreign Body In Patient

  MAUDE report 24116056 ↗
• MalfunctionOct 6, 2025Fracture; Fracture

  AS REPORTED: "EXTRACTION OF AN ASNIS 4MM SCREW WAS DIFFICULT BECAUSE THE SCREW WAS BENT IN THE BONE. THE EXTRACTOR WAS USED TO REMOVE THE SCREW, BUT THE TIP OF THE EXTRACTOR BROKE OFF. ALL FRAGMENTS WERE REMOVED.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23222590 ↗
• MalfunctionJun 2, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "CONICAL EXTRACTOR TIP SNAPPED OFF WHEN UTILIZED FOR REMOVAL OF PATIENTS' CANNULATED SCREWS. SPD STAFF DISPOSED OF BROKEN INSTRUMENTS".

  Patient problems: Insufficient Information

  MAUDE report 22126352 ↗
• MalfunctionApr 23, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "THE EXTRACTOR WAS BROKEN DURING THE EXTRACTION FOR ASNIS 4.0 SCREW.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21896007 ↗
• InjuryMar 13, 2025Break; Fracture; Break; Fracture

  WHEN EXTRACTING THE ASNIS SCREW THAT HAD BEEN INSERTED INTO THE DISTAL END OF THE HUMERUS, THE SCREW WAS LEFT IN THE PATIENT'S BODY IN A DAMAGED STATE AND COULD NOT BE REMOVED AND THE EXTRACTOR WAS BROKE OFF. THE SCREW COULD NOT BE REMOVED AND PART OF IT REMAINED. AS A RESULT, THE SCREW REMAINED IN THE PATIENT. ALL THE DEBRIS WERE REMOVED FROM THE SURGICAL FIELD/PATIENT.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 21595222 ↗
• MalfunctionFeb 25, 2025Break; Fracture; Break; Fracture

  TIP OF THE EXTRACTOR BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457034 ↗
• InjuryFeb 18, 2025Break; Fracture; Break; Fracture

  PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2023. BONE FUSION WAS ACHIEVED AND REVISION SURGERY FOR EXPLANTATION WAS PERFORMED ON (B)(6) 2025. THE HEAD OF ASNIS SCREW WAS DEFORMED WHEN REMOVING THE SCREW. SURGEON USED THE EXTRACTOR TO REMOVE THE DEFORMED SCREW. HOWEVER, THE TIP OF THE EXTRACTOR WAS BROKEN. SURGEON TRIED TO REMOVE THE SCREW WITH USING PILERS, HOWEVER, THE HEAD OF SCREW WAS BROKEN AND THE SCREW COULD NOT BE REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21398118 ↗
• InjuryApr 26, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2023. REVISION SURGERY FOR REMOVE THE IMPLANTS DUE TO BONE UNION COMPLETED ON (B)(6) 2024. DURING PROCEDURE, SCREW AND EXTRACTOR WAS FRACTURED AND REMAINED IN THE PATIENT BODY. THE SURGEON DECIDE TO REMAIN THESE PIECES IN THE PATIENT, PROCEDURE WAS COMPLETED."

  Patient problems: Foreign Body In Patient

  MAUDE report 19197471 ↗
• MalfunctionOct 2, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "WHEN THE EXTRACTOR FOR 4MM SCREWS WAS USED IN THE ASNIS III REMOVAL SURGERY, THE TIP PART OF THE EXTRACTOR WAS BROKEN. THE FRAGMENT WAS REMOVED AND THE SURGERY WAS COMPLETED WITHOUT PROBLEM AFTER THAT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17850768 ↗
• MalfunctionMar 28, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "THE ASNIS 4.0 WAS BROKEN DURING REMOVAL SURGERY. THE DOCTOR ATTEMPTED TO REMOVE THE BROKEN SCREW USING THE EXTRACTOR FOR 4.0 MM DIAMETER IN THE ASNIS 4.0 EXTRACTION SET, BUT THE TIP OF THE EXTRACTOR WAS ALSO BROKEN (CHIPPED). THE BROKEN EXTRACTOR TIP WAS REMOVED EVENTUALLY. HOWEVER, ONLY THE HEAD OF THE SCREW COULD BE REMOVED AND THE DOCTOR CLOSED SURGICAL INCISION WHILE THE THREAD PART OF THE SCREW WAS LEFT IN THE PATIENT'S BODY. ONLY THE SHAFT OF THE EXTRACTOR WILL BE RETURNED FROM THE FACILITY. BROKEN TIP OF THE EXTRACTOR AND HEAD OF THE SCREW WERE DISPOSED AT THE HOSPITAL AFTER REMOVAL." ADDITIONALLY A 30 MINUTE SURGICAL DELAY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16628599 ↗
• MalfunctionJan 30, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "DURING SCREW EXTRACTION, THE TIP WAS BROKEN." IT IS UNKNOWN WHY, BUT THE PATIENT REQUESTED TO HAVE THE SCREW REMOVED. ALL THE DEBRIS WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16264706 ↗
• MalfunctionJan 13, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT AN EXTRACTION TOOK PLACE DUE TO A REFRACTURE. DURING THE PROCEDURE THE TIP OF THE EXTRACTOR BROKE. WHAT LOOKS LIKE A VERY SMALL PIECE OF DEBRIS IS VISIBLE ON THE X-RAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16163083 ↗
• MalfunctionJan 4, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "THE TIP BROKE DURING AN EXTRACTION SURGERY AFTER BONE FUSION. ALL THE DEBRIS WERE REMOVED FROM THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16099340 ↗
• MalfunctionDec 19, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A PLANNED EXTRACTION OF A PLATE THE TIP OF THE DRIVER BROKE. THE DEBRIS FROM THE DRIVER TIP WAS REMOVED FROM THE PATIENT, HOWEVER A SCREW BECAME DIFFICULT TO REMOVE, AND THE THREADED PORTION OF THE SCREW WAS RETAINED IN THE PATIENT BODY BECAUSE THE SCREW HEAD WAS FORCIBLY GRASPED AND ATTEMPTED TO BE REMOVED, BUT BROKE OFF. ONLY THE THREADED PORTION OF THE SCREW WAS LEFT IN THE PATIENT'S BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16010385 ↗
• MalfunctionMar 31, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "THE EXTRACTOR FOR 4.0 MM DIAMETER WAS BROKEN OFF DURING THE EXTRACTION SURGERY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13966053 ↗
• InjuryJan 12, 2022Break; Break

  AS REPORTED: "DURING REMOVAL, THE SCREW STOPPED IN THE MIDDLE AND THE TIP OF THE EXTRACTOR BROKE OFF WHEN THE SURGEON KEPT TURNING IT. THE BONE AROUND THE SCREW WAS THEN DRILLED USING A CROWN DRILL AND THE SCREW WAS REMOVED. IN DOING SO, THE DRILL TIP MAY HAVE HIT THE SCREW AND CHIPPED IT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13235386 ↗
• MalfunctionOct 29, 2020Fracture; Fracture

  WHEN PULLING OUT THE AZNIS 4.0 MM SCREW WHICH WAS INSERTED IN THE TIBIAL MEDIAL MALLEOLUS, THE SURGEON USED AN EXTRACTOR (4.0MM IN DIAMETER). AS THE PATIENT HAD GOOD BONE QUALITY, IT WAS DIFFICULT TO REMOVE AND THE EXTRACTOR BROKE DURING REMOVAL. AFTER THAT, THE SURGEON USED PLIERS OWNED BY THE HOSPITAL, AND THE PROCEDURE COMPLETED WITHOUT PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10757213 ↗
• MalfunctionSep 4, 2020Break; Break

  AS REPORTED: "THE TIP OF THE EXTRACTOR WAS DAMAGED DURING REMOVAL." DAMAGE OBSERVED: BREAKAGE.

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

  MAUDE report 10496897 ↗
• MalfunctionDec 5, 2019Break; Break

  AS REPORTED: "ATTEMPTED TO REMOVE THE SCREW, IT WAS BROKEN THE INSTRUMENT. THEN OTHER INSTRUMENT WAS USED AND REMOVED THE SCREW."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9420734 ↗
• MalfunctionSep 17, 2019Contamination; Contamination /Decontamination Problem; Contamination

  AS REPORTED: "IT WAS REPORTED THAT WHEN PREPARATION OF SURGERY TO REMOVE ASNISS AFTER BONE FUSION, THE FOREIGN MATTER WAS CONFIRMED ON THE EXTRACTOR." PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED.

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

  MAUDE report 9079682 ↗
• MalfunctionAug 27, 2019Break; Naturally Worn; Break

  AS REPORTED: "ASNIS 4.0 EXTRACTION SURGERY DUE TO BONE HEALING WAS PERFORMED ON (B)(6) 2019. PRIMARY SURGERY WAS PERFORMED WITHIN A YEAR. THE PATIENT BONE QUALITY WAS SO HARD, THE HEX OF THE SCREW HEAD WORN DURING THE EXTRACTION USING THE HEX SOLID DRIVER. AFTER THAT THE SURGEON TRIED TO REMOVE THE SCREW USING THE EXTRACTOR, BUT THE TIP OF THE EXTRACTOR BROKE AS SOON AS HE STARTED USING. THE SCREW WAS REMOVED WITH ANOTHER INSTRUMENTS THAT THE HOSPITAL HAS FINALLY, THE PROCEDURE WAS FINISHED." PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8935585 ↗
• MalfunctionJul 16, 2018Break; Entrapment of Device

  WHEN THE ASNIS 4.0 WAS REMOVED , THE HEAD WAS STRIPPED. THEREFORE, THE EXTRACTOR WAS INSERTED INTO THE ASNIS SCREW, BUT THE EXTRACTOR WAS BROKEN TO PUT TORQUE. AFTER THAT, THE ASNIS AND THE TIP OF THE EXTRACTOR WAS LEFT IN THE PATIENT BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 7691944 ↗