NA 02.127.130Recalls & reported problems
Synthes GmbH · 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/30MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982043191), received between Jan 16, 2018 and Nov 7, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device-Device Incompatibility1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 7, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED WHILE DOING A COMPLEX TIBIAL PLATEAU ORIF THE REGISTRAR FOUND THAT ONE OF THE LAST LOCKING SCREWS GOING INTO THE VA PROXIMAL TIBIAL PLATE WOULDN'T LOCK WITH THE TORQUE LIMITING SCREWDRIVER. HE THEN REMOVED THE SCREW AND NOTED THAT THE HEAD HAD NO THREADS. I'M NOT SURE IF THE HEADS HAD BEEN STRIPPED BY HIM PUTTING IT INTO THE PLATE (POSSIBLY IN THE WRONG HOLE) OR THE SCREW WAS DEFECTIVE. SURGERY WAS DELAYED 1 MINUTE. PROCEDURE COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23497600 ↗InjuryJan 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF A 1 PLATE, 4 CORTEX SCREW. 4 VARIABLE ANGLE LOCKING COMPRESSION SCREW AND 1 METAPHYSEAL SCREW ON (B)(6) 2017 DUE TO RIGHT TIBIAL INFECTION. THE PLATE AND SCREWS WERE ORIGINALLY IMPLANTED ON AN UNKNOWN DATE. THE DEVICES WERE REMOVED INTACT AND AN ANTIBIOTIC NAIL WAS IMPLANTED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED AS FINE. THE PATIENT MAY BE SCHEDULED FOR ADDITIONAL SURGERIES AS PART OF A STAGED RE-IMPLANTATION. THIS COMPLAINT IS FOR TEN (10) DEVICES. (B)(4).
Patient problems: Unspecified Infection
MAUDE report 7194267 ↗
Other Screw, fixation, bone devices
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- 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.
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