OSTEORAPTOR 72203290Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00885554022254), received between Sep 6, 2018 and Apr 8, 2026 — classified as 12 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Fracture

  IT WAS REPORTED THAT, DURING A GLENOID REPAIR, AFTER THE INSERTION SITE WAS PREPARED USING AN ANCHOR MATCHING INSTRUMENT AND CLEARED OF ALL DEBRIS, AN OSTEORAPTOR ANCHOR FRACTURED, RESULTING IN IMPLANT FAILURE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP, IN THE ORIGINALLY DRILLED BONE HOLE. NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24824395 ↗
• InjuryMay 23, 2023Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING ARTHROSCOPY, THE OSTEORAPTOR ANCHOR DID NOT FIX. IT WAS NECESSARY TO DRILL AN ADDITIONAL HOLE TO USE THE BACK UP DEVICE, A VOID WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation; Rupture

  MAUDE report 16986728 ↗
• InjuryNov 4, 2022Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER JOINT GLENOID LABRUM REPAIR SURGERY, THE SUTURE OF THREE (3) OSTEORAPTOR BROKE UP WHILE BEING KNOTTED AFTER THE ANCHOR WAS INSERTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SIGNIFICANT DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation; Rupture

  MAUDE report 15731070 ↗
• InjuryOct 13, 2022Break; Break

  IT WAS REPORTED THAT DURING A LABRUM REPAIR SURGERY THE OSTEORAPTOR ANCHOR BROKE WHILE IMPLANTATION. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. IT IS UNKNOWN IF A SURGICAL DELAY OCCURRED TO THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15595954 ↗
• InjuryAug 15, 2022Break; Break

  IT WAS REPORTED THAT DURING A LIGAMENT REPAIR SURGERY, AN OSTEORAPTOR´S ANCHOR BROKE WHILE IMPLANTATION. SURGERY RESUMED AFTER A NON-SIGNIFICANT DELAY WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15223142 ↗
• InjuryMay 4, 2022Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE OSTEORAPTOR ANCHOR FRACTURED WHEN IT WAS CREWED IN. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14279670 ↗
• InjuryNov 8, 2021Break; Break

  IT WAS REPORTED THAT DURING A LABRUM SUTURE PROCEDURE, WHEN THE OSTEORAPTOR ANCHOR WAS DEPLOYED, THE INSERTER BROKE AND ONLY THE HANDLE OF THE DEVICE CAME OFF. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT. THERE WAS NO DELAY REPORTED, BUT IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12771656 ↗
• InjuryMay 7, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ACETABULAR LABRUM, THE OSTEORAPTOR SUTURE BROKE OFF AFTER THE ANCHOR WAS IMPLANTED. THE BROKEN PIECE WAS NOT REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND 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: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 11794305 ↗
• MalfunctionNov 2, 2020Break; Break

  IT WAS REPORTED THAT DURING ACL SURGERY, THE OSTEORAPTOR SUTURE RIPPED WHILE KNOTTING; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE IN A NEW HOLE. 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 10770670 ↗
• InjuryNov 2, 2020Break; Break

  IT WAS REPORTED THAT DURING ACL SURGERY, THE OSTEORAPTOR SUTURE RIPPED WHILE KNOTTING; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE IN A NEW HOLE. 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 10770639 ↗
• InjuryNov 2, 2020Break; Break

  IT WAS REPORTED THAT DURING ACL SURGERY, THE OSTEORAPTOR SUTURE RIPPED WHILE KNOTTING; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE IN A NEW HOLE. 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 10770635 ↗
• InjurySep 23, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE "2.3MM OSTEORAPTOR ANCHOR" DID NOT FIX. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE INTO AN ADDITIONAL BONE HOLE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  MAUDE report 10577454 ↗
• InjuryJul 17, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION AND INTERNAL FIXATION OF LEFT FIFTH METATARSAL FRACTURE, THE ANCHOR WAS FRACTURED WHEN SCREW IN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BACKUP DEVICE AND NO SIGNIFICANT DELAY OR FURTHER COMPLICATIONS 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 10292265 ↗
• InjuryApr 27, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING SURGERY THE OSTEORAPTOR GAVE OF LOTS OF METAL DEBRIS WHEN DRILLING ANCHOR HOLES, ALL THE METAL WAS REMOVED FROM THE JOINT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. A DELAY OF 5 MINUTES WAS REPORTED. NO PATIENT INJURY OR 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 Known Impact Or Consequence To Patient

  MAUDE report 9999638 ↗
• MalfunctionNov 7, 2018Break

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN IMPACTING THE ANCHOR ON THE PATIENT, WHEN THE PHYSICIAN WAS WITHDRAWING THE GUIDE ALONG WITH THE DEVICE, A PART OF THE WIRE BROKE NEAR THE BONE. THERE WAS NO BACKUP DEVICE AVAILABLE AND NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8046034 ↗
• MalfunctionOct 30, 2018Break

  IT WAS REPORTED THAT DURING A GLENOID LABRUM REPAIR SURGERY, THE ANCHOR BROKE. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8021589 ↗
• MalfunctionSep 6, 2018Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE SURGERY THE OUTER CORE OF ULTRABRAID SUTURE GOT CUT OFF AND INNER CORE OF ULTRABRAID SUTURE WAS INTACT. SO THE DOCTOR REVISED WITH ANOTHER ANCHOR. PIECES OF THE ANCHOR WERE REMOVED. NO PATIENT INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7851433 ↗

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-0172-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product Number: 72203708
• Z-0141-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors Product Number:72200777
• Z-0161-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620
• Z-0169-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705
• Z-0144-2021 · Sep 9, 2020 · Open, Classified
  ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494
• Z-0147-2021 · Sep 9, 2020 · Open, Classified
  RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805
• Z-0139-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Number: 7210712
• Z-0160-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616
• Z-0170-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706
• Z-0155-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602
• Z-0154-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165
• Z-0140-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number: 7210713
• Z-0152-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995
• Z-0163-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626
• Z-0164-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Number: 72202631

…and 25 more.