ASNIS 325070SRecalls & reported problems
Stryker GmbH · Cannulated Screw · Class 2 · Implant
All models of ASNIS (51)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327076257), received between Apr 4, 2017 and Jun 2, 2023 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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 18, 2026.
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Fracture1
- Material Disintegration1
- Material Fragmentation1
Patient problems
- No Known Impact Or Consequence To Patient2
- Laceration(s)1
- Nerve Damage1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 2, 2023Material Fragmentation; Material Fragmentation
AS REPORTED: "AN ASNIS 4.0 SCREW WAS INSERTED INTO A PATIENTS MEDIAL EPICONDYLE. THE SCREW DE-THREADED AND SOME OF THE THREADS ENDED UP IN THE PATIENTS CUBITAL FOSSA WHICH CAUSED A LACERATION TO THE RADIAL NERVE."
Patient problems: Laceration(s); Nerve Damage
MAUDE report 17049920 ↗MalfunctionSep 20, 2019Break; Fracture; Detachment of Device or Device Component; Fracture
THE CUSTOMER REPORTED THAT THE TIP OF THE SCREW HAS BROKEN OFF AND REMAINS IN THE PATIENT. THE SURGEON REPORTS NO ISSUE WITH THE PRE-DRILL FOR THE SCREW AND THE K-WIRE THAT THE SCREW WAS PASSED OVER IS NOT BENT. THE SURGEON IS SATISFIED THAT NO ADDITIONAL HARM WILL OCCUR LEAVING THE SCREW AND MORE DAMAGE COULD OCCUR IF IT WAS REMOVED. THE TIP OF THE THREADED END OF THE SCREW BROKE OFF, APPROXIMATELY 3 FULL THREADS. PATIENT HAD GOOD BONE. NO ISSUES DRILLING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9099399 ↗InjuryApr 4, 2017Material Disintegration; Device Dislodged or Dislocated
AFTER THE INSTALLATION, THE END OF THE SCREW HAS DISINTEGRATED. INITIAL SURGERY ON (B)(6) 2017. REVISION SURGERY ON (B)(6) 2017. ACCORDING TO THE REP, THE END OF THE SCREW HAS BACKED OUT, IT IS UNKNOWN AT THIS STAGE IF THE SCREW BROKE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6457976 ↗
Other Screw, fixation, bone devices
- NA 03.043.029Synthes GmbH · Screw, fixation, bone503 reports
- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page