OSTEORAPTOR 72201824Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010648068), received between Sep 28, 2020 and Nov 26, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, AN OSTEORAPTOR ANCHOR WAS PLACED, BUT WHEN TYING THE SUTURES DOWN, THE ANCHOR PULLED OUT OF THE HOLE. THE NEXT 3 ANCHORS WHEN IN WITHOUT AN ISSUE. THEN, A 5TH OSTEORAPTOR HAD THE SAME ISSUE AS THE FIRST ONE AND PULLED OUT AS KNOT WAS GETTING TIED. THE SURGEON MENTIONED THAT ALL THE ANCHORS FELT LOOSE WHEN PUSHING INTO BONE THROUGH THE GUIDE. THE DRILL WAS INSPECTED AND IT LOOKED TO BE SLIGHTLY BENT AT THE TIP SO POTENTIALLY DRILLED BIGGER HOLES. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A DIFFERENT DRILL BIT. FOR THE FIRST ANCHOR THAT PULLED OUT OF THE BONE HOLE, A 2.9 OSTEORAPTOR WAS PLACED AS A BACK-UP IN THE ORIGINAL DRILLED BONE HOLE, AND FOR THE FIFTH ANCHOR THAT ALSO PULLED OUT, A 2.3 OSTEORAPTOR WAS PLACED AS A BACK-UP, BUT, IN AN ADDITIONAL DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 20784884 ↗
• InjuryNov 17, 2024Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, TIP OF THE DRILL FLUTED BROKE OFF, AND THE BROKEN PIECE WAS LEFT INSIDE THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 20702945 ↗
• InjuryFeb 24, 2021Break; Break

  IT WAS REPORTED THAT, DURING LABRAL REPAIR SURGERY THE DRILL FLUTED 2.6MM FOR 2.3MM ANCHOR BROKE OFF IN THE ACETABULAR RIM. IT¿S CURRENTLY EMBEDDED IN THE PATIENT'S BONE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 11374777 ↗
• InjuryDec 15, 2020Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER PROCEDURE, THE DRILL BIT BROKE IN THE PATIENT WHILE DRILLING, THE DRILL FRAGMENT WAS ABLE TO BE RETRIEVED WITH AN ARTHROSCOPIC GRASPER. A VOID WAS LEFT AND A NEW BONE HOLE WAS USED TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11009285 ↗
• InjurySep 28, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SURGERY THE DRILL BIT BROKE IN THE PATIENT WHILE DRILLING. IT IS UNKNOWN IF THERE WAS AN AVAILABLE BACK UP DEVICE OR A SIGNIFICANT DELAY DURING THE PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10597200 ↗