AnchorKnot Suture Passer (2-0) PSZ-400-305Recalls & reported problems
Baylis Médicale Cie Inc · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00685447001744), received between Jul 31, 2019 and Jul 31, 2019 — classified as 1 malfunction.
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
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE ANCHORKNOT SUTURE PASSER WAS USED IN A HERNIATED DISC REPAIR PROCEDURE. UPON PLACEMENT OF THE SUTURE PASSER, THE DEVICE WAS TORQUED AND THE TIP BROKE OFF WITHIN THE DISC. AT THIS TIME, THE FIRST TRIGGER HAD NOT BEEN PULLED AND THE SUTURE WAS NOT DEPLOYED. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE BROKEN TIP USING A NERVE HOOK AND A MICRO PITUITARY RONGEUR. X-RAYS VIEWS WERE TAKEN THAT SHOWED THE BROKEN TIP WITHIN THE DISC SPACE. THE PHYSICIAN THEN DECIDED TO LEAVE THE TIP WHERE IT WAS AND CLOSE. THE PHYSICIAN LATER CONFIRMED THAT AN UNSUCCESSFUL ATTEMPT WAS MADE TO RETRIEVE THE TIP. SUBSEQUENTLY THE PHYSICIAN DETERMINED THROUGH X-RAY IMAGING INTRAOPERATIVELY THAT THE TIP WAS FULLY CONTAINED WITHIN THE DISC SPACE AND THERE WAS LIMITED RISK OF MIGRATION AND HE DECIDED TO LEAVE THE TIP WITHIN THE DISC. IN A FOLLOW-UP X-RAY IMAGE, IT WAS NOTED THAT THE DEVICE TIP HAD MIGRATED TO THE ANTERIOR PORTION OF THE LEFT PEDICLE. NO COMPLICATIONS WERE ASSOCIATED WITH THE DEVICE MIGRATION. NO OTHER ADVERSE EFFECTS WERE REPORTED. THE PHYSICIAN ENQUIRED ABOUT THE MRI COMPATIBILITY OF THE TIP MATERIALS, AND WAS INFORMED THAT THE DEVICE IS MANUFACTURED WITH MATERIALS THAT ARE NOT MRI-COMPATIBLE.
Patient problems: Device Embedded In Tissue or Plaque; No Code Available
MAUDE report 8849094 ↗
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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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