NA 04.005.570Recalls & reported problems
Synthes GmbH · 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 80MM FOR IM NAILS · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982086389), received between Jul 19, 2022 and Jul 19, 2022 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) [SUMMARY OF RETROSPECTIVE DATA FOR PATIENTS TREATED WITH THE LATERAL FEMORAL NAIL, ADOLESCENT LATERAL FEMORAL NAIL, AND THE FEMORAL RECON NAIL]. BETWEEN JANUARY 2014 AND OCTOBER 2021, A TOTAL OF 300 PATIENTS (219 PATIENTS TREATED WITH LFN, 56 PATIENTS TREATED WITH ALFN, AND 25 PATIENTS TREATED WITH FRN) WERE INCLUDED IN THE REPORT IF THEY HAD EITHER 9 MONTHS OF FOLLOW-UP OR EVIDENCE OF HEALING. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED IN THE BRONSON METHODIST HOSPITAL¿S ORTHOPEDIC INPATIENT DATABASE: LFN GROUP: PATIENT 5: A 32-YEAR-OLD MALE PATIENT HAD A WEAKNESS IN LEG, WHICH RESOLVED WITH PHYSICAL THERAPY. PATIENT 6: AN 81-YEAR-OLD MALE PATIENT HAD A PERSISTENT SWELLING ABOUT KNEE 1.5 YEARS POSTOPERATIVELY, COMPRESSION. PATIENT 8: A 58-YEAR-OLD FEMALE PATIENT HAD A PULMONARY EMBOLISM. PATIENT 9: A 35-YEAR-OLD FEMALE PATIENT HAD DIFFICULT REDUCTION INTRAOPERATIVELY AND HAD RESIDUAL SORENESS AT INCISION SITE POSTOPERATIVELY. PATIENT 13: A 16-YEAR-OLD MALE PATIENT HAD PAIN WITH IMPLANTS LEADING TO REHOSPITALIZATION FOR ADJUNCTIVE PLATE REMOVAL, L
Patient problems: Swelling/ Edema
MAUDE report 15052744 ↗
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- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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