OSTEORAPTOR 72201992Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010615534), received between Jan 5, 2018 and Jun 11, 2025 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

40 other recalls cover devices cleared under the same FDA submission (K151105); they may or may not involve this specific model.

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

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, WHEN THE OSTEORAPTOR ANCHOR WAS BEING IMPLANTED AND THE SUTURE WAS TYING, THE SUTURE WAS BROKEN. THE ANCHOR COULD NOT BE REMOVED FROM THE BODY, IT EAS LEFT SECURE IN PATIENT. THERE WAS A BACK UP DEVICE AVAILABLE AND IT WAS NECESSARY TO DRILL AN ADDITIONAL BONE HOLE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 22185423 ↗
• MalfunctionMar 28, 2024Break; Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, THE OSTEORAPTOR COBRAID ANCHOR WIRE BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18990443 ↗
• MalfunctionNov 29, 2023Break; Break

  IT WAS REPORTED THAT DURING A TENDON REPAIR, THE OSTEORAPTOR ANCHOR BROKE AND COULD NOT BE PINNED TO THE BONE, NO DEBRIS LEFT IN THE PATIENT. THE BROKEN PIECES WERE REMOVED USING TWEEZERS AND THE PROCEDURE WAS COMPLETED WITH A TWINFIX TI. THERE WAS A DELAY OF 15 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18235104 ↗
• MalfunctionJul 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE OSTEORAPTOR ANCHOR FAILED IMPLANTATION, WHEN IT WAS INSERTED INTO THE BONE HOLE AND THE KNOB WAS PULLED, THE ANCHOR PULLED OUT FROM THE BONE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17250455 ↗
• InjurySep 24, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE OSTEORAPTOR SUTURE ANCHOR CAME OUT WHILE TIGHTENING THE KNOT. THE ANCHOR WAS SUCCESSFULLY REMOVED FROM THE BONE WITH A GRASPER. A NON-SIGNIFICANT DELAY WAS REPORTED, AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15476945 ↗
• InjurySep 8, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE THREAD OF THE OSTEORAPTOR 2.3 SUTURE ANCHOR GOT CUT NEAR THE ANCHOR DURING TYING THE KNOT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12442065 ↗
• InjuryDec 29, 2020Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, DURING THE INSERTION OF THE ANCHOR, IT WAS BENT AND BROKEN. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE. NO SIGNIFICANT DELAY AND NO PATIENT 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 11091647 ↗
• MalfunctionFeb 11, 2019Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A HIP LABRUM REPAIR PROCEDURE, THE SURGEON WAS USE A 2.3MM SURGICAL TECHNIQUE BUT THE PATIENT BONE WAS SOFT ENOUGH TO PUT OUT THE ANCHOR FROM THE PATIENT. AFTER THAT, THE SURGEON WAS REMOVED THE IMPLANT FROM THE PATIENT AND A BACKUP IMPLANT WAS USED TO FINISH SUCCESSFULLY AND WITHOUT A DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8324872 ↗
• MalfunctionJan 5, 2018Material Deformation

  IT WAS REPORTED THAT THE ANCHOR SMASHED AS IT WAS BEING POUNDED IN. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE FOLLOWING A SHORT DELAY. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7167442 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151105. One submission often covers many models, so check the product and lot details in each record.

• Z-0146-2021 · Sep 9, 2020 · Open, Classified
  BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702
• Z-0164-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Number: 72202631
• Z-0154-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165
• Z-0157-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Number: 72202608
• Z-0142-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number: 72200785
• Z-0174-2021 · Sep 9, 2020 · Open, Classified
  MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204983
• Z-0137-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710
• Z-0167-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203697
• Z-0162-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202624
• Z-0166-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Number: 72203291
• Z-0151-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994
• Z-0160-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616
• Z-0159-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612
• Z-0148-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991
• Z-0171-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707

…and 25 more.