OSTEORAPTOR / ULTRABRAID 72201991Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010615527), received between Oct 25, 2017 and Jun 12, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF ARTHROSCOPY, WHEN THE OSTEORAPTOR ANCHOR WAS INSERTED INTO THE BONE HOLE, IT WAS BROKEN. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. IT IS UNKNOWN HOW THE SURGERY WAS COMPLETED. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22199833 ↗
• MalfunctionFeb 25, 2021Break; Break

  IT WAS REPORTED THAT THE OSTEORAPTOR'S TIP BROKE DURING INSERTION IN AN UNKNOWN PROCEDURE. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT BY SUCTION, AND THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO DELAYS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11382278 ↗
• MalfunctionFeb 25, 2021Break; Break

  IT WAS REPORTED THAT THE OSTEORAPTOR'S TIP BROKE DURING INSERTION IN AN UNKNOWN PROCEDURE. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT BY SUCTION, AND THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO DELAYS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11382275 ↗
• MalfunctionJun 1, 2018Fracture; Loose or Intermittent Connection; Sticking

  IT WAS REPORTED THAT WHEN THE PACKAGE WAS OPENED, SUTURE WAS LOOSEN AND ANCHOR WAS NOT ATTACHED TO SHAFT PROPERLY. THE SURGEON TRIED TO USE THE DEVICE USING GUIDE, BUT SUTURE WAS STUCK AND ANCHOR COULD NOT BE INSERTED. A FRACTURE IN THE ANCHOR WAS FOUND IN THE SAMPLE EVALUATION. NO PATIENT INJURY OR DELAY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7560660 ↗
• MalfunctionNov 21, 2017Break; Detachment Of Device Component

  IT WAS REPORTED THAT THE DISTAL END OF THE ANCHOR BROKE OFF UPON INSERTION. A BACKUP DEVICE WAS READILY AVAILABLE TO COMPLETE THE PROCEDURE WITH A SHORT DELAY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7051312 ↗
• MalfunctionNov 2, 2017Break

  IT WAS REPORTED THAT ANCHOR SNAPPED WHILE BEING MALLETTED INTO HOLE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6997826 ↗
• MalfunctionOct 25, 2017Break; Detachment Of Device Component

  IT WAS REPORTED THAT THE DISTAL END OF THE ANCHOR BROKE OFF UPON INSERTION. A BACKUP DEVICE WAS READILY AVAILABLE AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6976803 ↗

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-0137-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710
• Z-0157-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Number: 72202608
• 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-0136-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309
• Z-0174-2021 · Sep 9, 2020 · Open, Classified
  MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204983
• Z-0159-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612
• 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-0175-2021 · Sep 9, 2020 · Open, Classified
  MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984
• Z-0158-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 72202610
• 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-0146-2021 · Sep 9, 2020 · Open, Classified
  BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702
• Z-0161-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620
• Z-0155-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602
• 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

…and 25 more.