BIORAPTOR / ULTRABRAID 72201702Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010607553), received between Dec 14, 2017 and Nov 25, 2019 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 18, 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.

• MalfunctionNov 25, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN ELBOW PROCEDURE, THE BIORAPTOR ANCHOR BROKE. ALL FRAGMENTS WERE RETRIEVED FROM WITHIN THE PATIENT. AN ADDITIONAL BONE HOLE HAD TO BE DRILLED IN ORDER TO USE THE BACKUP DEVICE WHICH WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY OR PATIENT INJURY WAS 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 9372046 ↗
• MalfunctionNov 25, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN ELBOW PROCEDURE, THE BIORAPTOR ANCHOR BROKE. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. AN ADDITIONAL BONE HOLE HAD TO BE DRILLED IN ORDER TO USE THE BACKUP DEVICE AVAILABLE. THE PROCEDURE WAS FINISHED WITH NO SIGNIFICANT DELAY OR PATIENT INJURY WAS 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 9371956 ↗
• InjuryNov 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER USING A BIORAPTOR SUTURE ANCHOR FOR A PRIMARY LATERAL LIGAMENT RECONSTRUCTION OF AN ANKLE ((B)(6) 2019), THE PATIENT DEVELOPED SECONDARY SEPSIS. ON (B)(6) 2019, THE ANCHOR HAD TO BE REMOVED DUE TO INFLAMMATION AND PAIN. ALTHOUGH NO PATHOGEN WAS IDENTIFIED IN THE INFECTION SITE, THE PATIENT WAS TREATED WITH WASHOUT OF WOUND AND INTRAVENOUS ANTIBIOTICS. THE PATIENT'S OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 9302890 ↗
• InjuryNov 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER USING A BIORAPTOR SUTURE ANCHOR FOR A PRIMARY LATERAL LIGAMENT RECONSTRUCTION OF AN ANKLE ((B)(6) 2018), THE PATIENT DEVELOPED SECONDARY SEPSIS. ON (B)(6) 2019, THE ANCHOR HAD TO BE REMOVED DUE TO INFLAMMATION AND PAIN. S. AUREUS WAS LOCATED IN THE INFECTION SITE. THE PATIENT WAS TREATED BY WASHOUT OF WOUND AND INTRAVENOUS ANTIBIOTICS. THE PATIENT'S OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 9302880 ↗
• InjuryNov 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER USING A BIORAPTOR SUTURE ANCHOR FOR A PRIMARY LATERAL LIGAMENT RECONSTRUCTION OF AN ANKLE ((B)(6) 2018), THE PATIENT DEVELOPED SECONDARY SEPSIS. ON (B)(6) 2019, THE ANCHOR HAD TO BE REMOVED DUE TO INFLAMMATION AND PAIN. ALTHOUGH NO PATHOGEN WAS IDENTIFIED IN THE INFECTION SITE, THE PATIENT WAS TREATED WITH A WASHOUT OF THE WOUND AND INTRAVENOUS ANTIBIOTICS. THE PATIENT'S OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 9302878 ↗
• MalfunctionApr 27, 2018Break

  IT WAS REPORTED THAT THE DEVICE BROKE INSIDE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7469196 ↗
• MalfunctionDec 14, 2017Bent; Break

  IT WAS REPORTED THAT DURING IMPLANTATION THE SUTURE ANCHOR BENT AND BROKE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7117096 ↗

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-0155-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602
• Z-0168-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704
• Z-0138-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711
• Z-0147-2021 · Sep 9, 2020 · Open, Classified
  RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805
• Z-0149-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992
• 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-0139-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Number: 7210712
• Z-0151-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994
• Z-0150-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993
• Z-0136-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309
• 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-0163-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626
• Z-0148-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991
• Z-0140-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number: 7210713

…and 25 more.