Rotation Medical Bone Staple 2503-SRecalls & reported problems
Smith & Nephew, Inc. · 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 00854501006111), received between Jun 14, 2021 and Jan 22, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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
- Device Markings/Labelling Problem1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Perforation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 22, 2026Material Deformation
IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, TWO (2) BONE ANCHORS HAD AN ISSUE. THE FIRST BONE ANCHOR WAS DEPLOYED WITH THE ARTHROSCOPIC ADVANCED DELIVERY SYSTEM DRIVER FOLLOWING THE PROPER STEPS. UPON REMOVING THE DRIVER, IT WAS NOTED THAT THE BONE ANCHOR IMPLANT LEG WAS CROOKED AND NOT PROPERLY SECURING THE REGENETEN IMPLANT. A SECOND BONE ANCHOR IMPLANT WAS OPENED AND DEPLOYED USING THE PROPER STEPS, BUT A SIMILAR ISSUE OCCURRED. BOTH ANCHORS WERE REMOVED WITH ARTHROSCOPIC GRASPERS. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP. IT WAS NECESSARY TO DRILL AN ADDITIONAL BONE HOLE. THE SECOND FAILED BONE ANCHOR WAS MEANT AS THE BACKUP FOR THE FIRST FAILED BONE ANCHOR. THERE WAS NO VISIBLE VOID LEFT. THE INSTRUMENT SIZE WERE BONE ANCHORS OF 10, 8 MM AND WIDTH OF 5 MM. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION. THE PATIENT WAS NOT EXPOSED TO ADDITIONAL ANESTHESIA. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Perforation
MAUDE report 24151161 ↗InjuryJun 14, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE IMPLANT BOX INDICATED AN EXPIRATION DATE OF JANUARY 2023 BUT THE CORRECT EXPIRATION DATE WAS JANUARY 2021. THE LABEL WAS PRINTED INCORRECTLY. THE BONE ANCHOR OPERATED AS EXPECTED AND THIS WAS NOTICED AFTER PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11996894 ↗
Other Fastener, Fixation, Nondegradable, Soft Tissue devices
- TRUESPAN ORTHOCORD 228151Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,686 reports
- TRUESPAN ORTHOCORD 228152Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,398 reports
- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 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