OSTEORAPTOR 72201994Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 03596010615558), received between May 13, 2018 and Jan 9, 2025 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, UNEVEN FORCE WAS APPLIED DURING PUSH ROD OPERATION, WHICH RESULTED ON THE BREAKAGE OF THE OSTEORAPTOR ANCHOR. ALL THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT WITH TWEEZERS. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE, NO VOID WAS LEFT. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21119152 ↗
• MalfunctionOct 11, 2024Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE OSTEORAPTOR 2.9 ANCHOR WAS BROKEN. IT WAS SUCCESSFULLY REMOVED FROM THE PATIENT. SURGERY WAS COMPLETED WITH A REJOIN DEVICE, INSTEAD, AND AN ADDITIONAL BONE HOLE WAS MADE. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT STATUS IS HEALTHY.

  Patient problems: Perforation

  MAUDE report 20429199 ↗
• MalfunctionJul 5, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE OSTEORAPTOR 2.9W ANCHOR BROKE WHILE BEING IMPLANTED. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE AND IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19680691 ↗
• MalfunctionFeb 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE OSTEORAPTOR COBRAID BLUE ANCHOR CAME OUT FROM THE BONE DESPITE BEING USED CORRECT DRILL. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18759606 ↗
• InjuryApr 19, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, THE OSTEORAPTOR ANCHOR BROKE. THE PROCEDURE WAS COMPLETED USING A BACK UP DEVICE BUT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773417 ↗
• InjuryJul 21, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, NOT KNOWN IF INTERNAL OR EXTERNAL TO PATIENT, THE OSTEORAPTOR ANCHOR BROKE. 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 15071789 ↗
• MalfunctionFeb 17, 2022Crack; Crack

  IT WAS REPORTED THAT DURING SURGERY, THE OSTEORAPTOR ANCHOR WAS FOUND TO BE FRACTURED. IT IS UNKNOWN IF THE DEVICE WAS INSIDE OR OUTSIDE THE PATIENT WHEN THE ISSUE WAS NOTICED. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13548986 ↗
• InjuryJul 28, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING USE IN AN UNKNOWN PROCEDURE, THE ANCHOR PULLED OUT FROM BONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12242244 ↗
• InjuryAug 6, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SHOULDER INSTABILITY SURGERY, THE ANCHOR WAS FOUND FRACTURED AND THEN REMOVED WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO DELAY OR FURTHER 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 10376687 ↗
• MalfunctionAug 12, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING BANKART SURGERY, THE SUTURE CUT INTO BONE WHILE TYING AND POSITION OF THE SUTURE ANCHOR SLIGHTLY MOVED OUT OF THE DRILL HOLE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND WITH A SIGNIFICANT DELAY. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8884268 ↗
• MalfunctionJun 4, 2019Material Separation; Material Integrity Problem; Material Separation; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY, THE ULTRABRAID SUTURE BROKE WHILE IT WAS PULLING AFTER INSERTING INTO GLENOID. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES. ADDITIONAL BONE HOLE WAS DRILLED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8666205 ↗
• MalfunctionMay 21, 2019Break

  IT WAS REPORTED THAT DURING A SURGERY, THE ANCHOR BROKEN WHEN IT WAS INSERTED. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8626453 ↗
• MalfunctionDec 26, 2018Break

  IT WAS REPORTED THAT DURING A SURGERY WHEN THE PHYSICIAN TRIED TO DO THE KNOTS, THE SUTURE BROKE AND WAS NOT ABLE TO TIE IT DOWN THE LABRUM. HE ASKED TO WAIVE THIS IMPLANT AND NEW IMPLANT WAS OPENED. A 2.9 DRILL SLEEVE WAS USED TO PREPARE THE INSERTION SITE. THE ANCHOR WAS LEFT INSIDE AS IT WAS DEEP INTO THE BONE THERE WAS NOT DELAY ON THE CASE AND PATIENT INJURY WAS NOT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8198380 ↗
• MalfunctionMay 13, 2018Device Dislodged or Dislocated

  IT WAS REPORTED THAT UPON ANCHORING THE ANCHOR ONTO THE BONE, THE SURGEON TRIED TO GIVE A LIGHT TUG ON THE SUTURE THAT COMES TOGETHER WITH ANCHOR TO ENSURE THE ANCHOR DID ANCHOR WELL ONTO THE BONE. HOWEVER WHILE SURGEON DID THIS, THE SUTURES GOTTEN DISLODGED FROM THE ANCHOR. 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 7509696 ↗

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-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
• Z-0138-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711
• 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-0140-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number: 7210713
• Z-0165-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290
• Z-0156-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603
• 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-0154-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165
• Z-0175-2021 · Sep 9, 2020 · Open, Classified
  MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984
• 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-0173-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203801
• Z-0166-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Number: 72203291
• Z-0144-2021 · Sep 9, 2020 · Open, Classified
  ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494
• Z-0145-2021 · Sep 9, 2020 · Open, Classified
  ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495
• Z-0142-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number: 72200785

…and 25 more.