ASNISRecalls & reported problems across all models
Stryker GmbH · 51 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 83
- Deaths reported
- 0
- Injuries reported
- 33
- Recalls
- 0
We found 51 models of ASNIS by Stryker GmbH in the FDA's device registry (GUDID). Together they are named in 83 adverse event reports in the FDA's MAUDE database, received between Apr 4, 2017 and Aug 20, 2026 — classified as 33 injuries, 50 malfunctions.
The most frequently reported specific device problem is “Fracture” (37 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ASNIS problems
Device problems
- Fracture37
- Break25
- Adverse Event Without Identified Device or Use Problem14
- Material Fragmentation13
- Material Deformation10
- Difficult to Remove5
- Material Twisted/Bent4
- Unraveled Material4
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Foreign Body In Patient18
- No Known Impact Or Consequence To Patient10
- Insufficient Information9
- Device Embedded In Tissue or Plaque7
- Implant Pain6
- Failure of Implant4
- Medical device site infection4
ASNIS models
51 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ASNIS 604660SScrew, fixation, bone5 reports
- Asnis 45-30005SBIT, DRILL5 reports
- ASNIS 604640SScrew, fixation, bone4 reports
- ASNIS 325044SScrew, fixation, bone4 reports
- ASNIS 604644SScrew, fixation, bone3 reports
- ASNIS 604646Screw, fixation, bone3 reports
- ASNIS 325050SScrew, fixation, bone3 reports
- ASNIS 325070SScrew, fixation, bone3 reports
- ASNIS 325060SScrew, fixation, bone3 reports
- ASNIS 602690SScrew, fixation, bone2 reports
- ASNIS 604636SScrew, fixation, bone2 reports
- ASNIS 604638SScrew, fixation, bone2 reports
- ASNIS 604646SScrew, fixation, bone2 reports
- ASNIS 604670SScrew, fixation, bone2 reports
- ASNIS 325032SScrew, fixation, bone2 reports
- ASNIS 325046SScrew, fixation, bone2 reports
- ASNIS 325060Screw, fixation, bone2 reports
- ASNIS 601648SScrew, fixation, bone1 report
- ASNIS 602640SScrew, fixation, bone1 report
- ASNIS 602670SScrew, fixation, bone1 report
- ASNIS 602685SScrew, fixation, bone1 report
- ASNIS 602700SScrew, fixation, bone1 report
- ASNIS 604634Screw, fixation, bone1 report
- ASNIS 604648Screw, fixation, bone1 report
- ASNIS 604648SScrew, fixation, bone1 report
- ASNIS 604650Screw, fixation, bone1 report
- ASNIS 604650SScrew, fixation, bone1 report
- ASNIS 604655Screw, fixation, bone1 report
- ASNIS 604655SScrew, fixation, bone1 report
- ASNIS 604746SScrew, fixation, bone1 report
- ASNIS 606080SScrew, fixation, bone1 report
- ASNIS 611075SScrew, fixation, bone1 report
- ASNIS 611280SScrew, fixation, bone1 report
- Asnis 40-20114SScrew, fixation, bone1 report
- Asnis 40-20122SScrew, fixation, bone1 report
- Asnis 40-30118SScrew, fixation, bone1 report
- Asnis 40-30122SScrew, fixation, bone1 report
- Asnis 40-30120Screw, fixation, bone1 report
- ASNIS 325028SScrew, fixation, bone1 report
- ASNIS 325055SScrew, fixation, bone1 report
- ASNIS 325250SScrew, fixation, bone1 report
- ASNIS 325065SScrew, fixation, bone1 report
- ASNIS 326110SScrew, fixation, bone1 report
- ASNIS 325036Screw, fixation, bone1 report
- ASNIS 325044Screw, fixation, bone1 report
- ASNIS 325050Screw, fixation, bone1 report
- ASNIS 325070Screw, fixation, bone1 report
- ASNIS 601740Screw, fixation, bone1 report
- ASNIS 325240Screw, fixation, bone1 report
- ASNIS 325248Screw, fixation, bone1 report
- ASNIS 705366ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent ASNIS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 20, 2026No Apparent Adverse Event
It was reported that, after K-wire insertion and measurement, drilling was performed.During screw insertion, a bone fragment fractured. Although the attempt to insert the screw was abandoned, the tip of the screwdriver broke off in the process. The broken fragment was retrieved and discarded.
Patient problems: Bone Fracture(s)
MAUDE report 50356597 ↗MalfunctionMar 24, 2026Fracture
AS REPORTED: "WHEN INSERTING THE SCREW THROUGH THE GUIDE PIN, THE SURGEON FELT A FIRM RESISTANCE. CONTINUING TO INSERT IT, THE SCREWDRIVER BEGAN TO SLIP HALFWAY THROUGH. UPON REMOVING THE GUIDE PIN, THE SCREW ALSO CAME OUT. UPON INSPECTION, IT WAS FOUND THAT THE SCREW WAS BROKEN, AND THE REMAINING BROKEN SCREW FRAGMENT COULD NOT BE REMOVED FROM THE PATIENT'S BODY. THUS, THE SURGERY WAS COMPLETED WHILE THE SCREW FRAGMENT WAS LEFT IN THE PATIENT'S BODY."
Patient problems: Foreign Body In Patient
MAUDE report 24676896 ↗InjuryFeb 6, 2026Off-Label Use; Loosening of Implant Not Related to Bone-Ingrowth
AS REPORTED: "A BONE CUT (DTO) WAS PERFORMED USING PHITO PLATES AND ASNIS SCREW ON (B)(6) 2025. HOWEVER FLANGE LIFTING WAS OBSERVED POSTOPERATIVELY, NECESSITATING A SECOND SURGERY. REVISION SURGERY WAS PERFORMED ON JANUARY 13, 2026. INSERTED ASNIS SCREW WAS REMOVED AND 3 NEW ASNIS SCREWS WERE INSERTED FOR FIXATION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24278374 ↗InjuryJan 20, 2026Difficult to Remove
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 24115663 ↗InjuryNov 6, 2025Biocompatibility; Biocompatibility
IT WAS REPORTED THAT A PATIENT CONTACTED STRYKER TO CONFIRM THE MATERIAL COMPOSITION OF A 20MM PARTIALLY THREADED CANNULATED SCREW. THE PATIENT HAS A KNOWN COBALT ALLERGY AND IS EXPERIENCING LOW BLOOD PRESSURE IN THE EVENINGS, NAUSEA AFTER EATING, AND LOCALIZED REDNESS NEAR THE SURGICAL SITE (WITHOUT SIGNS OF INFECTION). THE PATIENT IS CONSIDERING IMPLANT REMOVAL, BUT INSURANCE WILL ONLY COVER THE REVISION IF COBALT EXPOSURE IS CONFIRMED, SO THEY ARE REQUESTING CLARIFICATION ON WHETHER THE SCREW CONTAINS COBALT OR IS PURE TITANIUM.
Patient problems: Erythema; Hypersensitivity/Allergic reaction; Low Blood Pressure/ Hypotension; Nausea
MAUDE report 23490591 ↗MalfunctionOct 29, 2025Fracture; Fracture
THE CUSTOMER REPORTED THAT: "PATIENT OPERATED ON (B)(6) 2024 FOR A BIMALLEOLAR FRACTURE WITH INSERTION OF TWO STRYKER SCREWS REF. 604660S BATCH K31308 AND ONE PLATE REF. 40-20903S BATCH 1000591836. SEVERAL ORTHOPEDIC CONSULTATIONS, INCLUDING ON (B)(60 2024 "MATERIAL VISIBLE TO THE NAKED EYE AND INFECTION ON MATERIAL" PROPOSAL TO REMOVE THE MATERIAL; LAST CONSULTATION ON (B)(6) 2025 WITH SCHEDULING OF OUTPATIENT REMOVAL (INFECTION WAS CONTROLLED BETWEEN THE PREVIOUS CONSULTATION AND THE LAST ONE WITH TRACEABILITY OF COMPLEX DRESSINGS). (PLEASE REFER TO COMPLAINTS (B)(4) ON (B)(6) 2025, REMOVAL IN DAY HOSPITAL IN ACCORDANCE WITH DECISION; (PLEASE REFER TO COMPLAINTS (B)(4). DURING EXPLANTATION OF THE MATERIAL INCOMPLETE, A SCREW BROKE IN THE BONE OF THE MALLEOLUS DURING ITS EXTRACTION. A PIECE OF THE SCREW COULD NOT BE REMOVED AND REMAINS IN THE TISSUE.
Patient problems: Foreign Body In Patient
MAUDE report 23418095 ↗InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT : "PATIENT OPERATED ON (B)(6) 2024 FOR A BIMALLEOLAR FRACTURE WITH INSERTION OF TWO STRYKER SCREWS REF. 604660S BATCH K31308 AND ONE PLATE REF. 40-20903S BATCH 1000591836. SEVERAL ORTHOPEDIC CONSULTATIONS, INCLUDING ON (B)(6) 2024 "MATERIAL VISIBLE TO THE NAKED EYE AND INFECTION ON MATERIAL" PROPOSAL TO REMOVE THE MATERIAL; LAST CONSULTATION ON (B)(6) 2025 WITH SCHEDULING OF OUTPATIENT REMOVAL (INFECTION WAS CONTROLLED BETWEEN THE PREVIOUS CONSULTATION AND THE LAST ONE WITH TRACEABILITY OF COMPLEX DRESSINGS). (PLEASE REFER TO COMPLAINTS (B)(4). ON (B)(6) 2025, REMOVAL IN DAY HOSPITAL IN ACCORDANCE WITH DECISION. DURING EXPLANTATION OF THE MATERIAL INCOMPLETE, A SCREW BROKE IN THE BONE OF THE MALLEOLUS DURING ITS EXTRACTION. (PLEASE REFER TO COMPLAINT (B)(4).
Patient problems: Medical device site infection
MAUDE report 23417937 ↗InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT: "PATIENT OPERATED ON (B)(6) 2024 FOR A BIMALLEOLAR FRACTURE WITH INSERTION OF TWO STRYKER SCREWS REF. 604660S BATCH K31308 AND ONE PLATE REF. (B)(4) BATCH 1000591836. SEVERAL ORTHOPEDIC CONSULTATIONS, INCLUDING ON (B)(6) 2024 "MATERIAL VISIBLE TO THE NAKED EYE AND INFECTION ON MATERIAL" PROPOSAL TO REMOVE THE MATERIAL; LAST CONSULTATION ON (B)(6) 2025 WITH SCHEDULING OF OUTPATIENT REMOVAL (INFECTION WAS CONTROLLED BETWEEN THE PREVIOUS CONSULTATION AND THE LAST ONE WITH TRACEABILITY OF COMPLEX DRESSINGS). (PLEASE REFER TO COMPLAINTS (B)(4)). ON (B)(6) 2025, REMOVAL IN DAY HOSPITAL IN ACCORDANCE WITH DECISION. DURING EXPLANTATION OF THE MATERIAL INCOMPLETE, A SCREW BROKE IN THE BONE OF THE MALLEOLUS DURING ITS EXTRACTION. (PLEASE REFER TO PI (B)(4)).
Patient problems: Medical device site infection
MAUDE report 23417932 ↗InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT: "PATIENT OPERATED ON (B)(6) 2024 FOR A BIMALLEOLAR FRACTURE WITH INSERTION OF TWO STRYKER SCREWS REF. 604660S, BATCH K31308 AND ONE PLATE REF. 40-20903S BATCH 1000591836. SEVERAL ORTHOPEDIC CONSULTATIONS, INCLUDING ON (B)(6) 2024 "MATERIAL VISIBLE TO THE NAKED EYE AND INFECTION ON MATERIAL" PROPOSAL TO REMOVE THE MATERIAL; LAST CONSULTATION ON (B)(6) 2025 WITH SCHEDULING OF OUTPATIENT REMOVAL (INFECTION WAS CONTROLLED BETWEEN THE PREVIOUS CONSULTATION AND THE LAST ONE WITH TRACEABILITY OF COMPLEX DRESSINGS). ON 10/02/2025, REMOVAL IN DAY HOSPITAL IN ACCORDANCE WITH DECISION; (PLEASE REFER TO COMPLAINTS (B)(4) DURING EXPLANTATION OF THE MATERIAL INCOMPLETE, A SCREW BROKE IN THE BONE OF THE MALLEOLUS DURING ITS EXTRACTION. (PLEASE REFER TO (B)(4).
Patient problems: Medical device site infection
MAUDE report 23417574 ↗InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT: "PATIENT OPERATED ON (B)(6) 2024 FOR A BIMALLEOLAR FRACTURE WITH INSERTION OF TWO STRYKER SCREWS REF. 604660S, BATCH: K31308 AND ONE PLATE REF. 40-20903S, BATCH: 1000591836. SEVERAL ORTHOPEDIC CONSULTATIONS, INCLUDING ON (B)(6) 2024 "MATERIAL VISIBLE TO THE NAKED EYE AND INFECTION ON MATERIAL" PROPOSAL TO REMOVE THE MATERIAL; LAST CONSULTATION ON (B)(6) 2025 WITH SCHEDULING OF OUTPATIENT REMOVAL (INFECTION WAS CONTROLLED BETWEEN THE PREVIOUS CONSULTATION AND THE LAST ONE WITH TRACEABILITY OF COMPLEX DRESSINGS). ON (B)(6) 2025, REMOVAL IN DAY HOSPITAL IN ACCORDANCE WITH DECISION; (PLEASE REFER TO COMPLAINTS (B)(4). DURING EXPLANTATION OF THE MATERIAL INCOMPLETE, A SCREW BROKE IN THE BONE OF THE MALLEOLUS DURING ITS EXTRACTION. (PLEASE REFER TO (B)(4)).
Patient problems: Medical device site infection
MAUDE report 23417537 ↗InjurySep 11, 2025Material Fragmentation; Material Fragmentation
AS REPORTED: "A LOANER INSTRUMENT TRAY WAS BROUGHT BY THE STRYKER REPRESENTATIVE AND STERILIZED FOR USE BY OUR CSR TEAM. PATIENT TAKEN TO OPERATING ROOM ON (B)(6) 2025 AND WAS UNDERGOING A ORIF (OPEN REDUCTION INTERNAL FIXATION) OF THE RIGHT PATELLAR. THE ORTHOPEDIC SURGEON INSERTED A 4.0 36 CANNULATED SCREW INTO THE RIGHT PATELLA. THE STRYKER VENDOR WAS PRESENT AND THE ENTIRE PROCEDURE WAS PERFORMED UNDER FLUOROSCOPY. WHEN INSERTING, THE SURGEON NOTED A PULLING SENSATION AND NOTED THAT THE SCREW APPEARED TO BE MOVING. UPON VISUALIZATION 2 SMALL THREADS OF THE SCREW WERE NOTED IN THE PATELLA. ONE FRAGMENT WAS IMMEDIATELY REMOVED ALONG WITH THE SCREW AND THE SECOND COULD NOT BE RETRIEVED, PER THE SURGEON, SINCE IT WAS IMBEDDED IN THE BONE. THE REMAINDER OF THE PROCEDURE (REPLACEMENT SCREW INSERTED) PROCEEDED WITHOUT INCIDENT. THE RIGHT KNEE WAS BANDAGED AND PLACED IN A KNEE IMMOBILIZER. THE PATIENT WAS RECOVERED IN PACU AND TRANSFERRED TO A MED/SURG UNIT IN STABLE CONDITION. THE PATIENT WAS INFORMED OF THE RETAINED FOREIGN BODY. SHE WAS MEDICATED FOR PAIN PRN".
Patient problems: Foreign Body In Patient
MAUDE report 23030660 ↗InjurySep 4, 2025Break; Fracture; Difficult to Remove; Break; Fracture; Difficult to Remove
AS REPORTED: "ONE SCREW OUT OF TWO WAS BROKEN DURING THE EXTRACTION OF AZUNIS 4.0.THE BROKEN SCREW PART BELOW THE SCREW HEAD WAS MANAGED TO BE REMOVED BY SHAVING THE BONE OF THE SURROUNDING AREA."
Patient problems: Insufficient Information
MAUDE report 22962737 ↗MalfunctionAug 18, 2025Material Fragmentation; Material Fragmentation
AS REPORTED: "DURING A SURGERY TO REPAIR A FRACTURED PATELLA THE SURGEON USED ASNIS 4.0 CANNULATED SCREWS. AFTER INSERTING THREE 1.4 THREADED K-WIRES HE DRILLED OVER THEM WITH THE 2.7 CANNULATED DRILL BIT. HE THEN INSERTED THE FIRST TWO SCREWS OVER THE WIRES UNTIL DESIRED COMPRESSION WAS ACHIEVED. DURING INSERTION OF THE THIRD SCREW THE SURGEON FELT UNUSUAL RESISTANCE AND DECIDED TO TAKE AN X-RAY. THE PICTURE REVEALED A METAL FRAGMENT IN THE PATELLA SEPARATE FROM THE SCREWS AND WIRES. AFTER DELIBERATION, THE SURGEON TOOK THE LAST SCREW OUT AND IT APPEARED AS THOUGH THE THREAD ON THE END OF THE SCREW HAD BROKEN OFF IN THE BONE. HE REMOVED AS MUCH OF THE FRAGMENT AS POSSIBLE AND PROCEEDED TO FINISH PLACING ANOTHER SCREW. HE MOVED ON TO CERCLAGE THE PATELLA AND FINISH THE SURGERY".
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 22835236 ↗MalfunctionAug 14, 2025Break; Fracture; Break; Fracture
AS REPORTED: "THE TIP OF THE HOLLOW DRILL WAS DAMAGED DUE TO DRILLING WITH FLEXURE."
Patient problems: Insufficient Information
MAUDE report 22805305 ↗InjuryMar 17, 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
MAUDE report 21621807 ↗
Other Stryker GmbH products
All Stryker GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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