BIORAPTOR/ULTRABRAID 72200775Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010585967), received between Mar 30, 2017 and Aug 27, 2024 — classified as 6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2024Difficult to Insert; Physical Resistance/Sticking; Difficult to Insert; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A CUFF SURGERY, WHEN PLACING THE ANCHOR HAD RESISTANCE UPON ENTRY. WHEN THE ANCHOR REACHED THE ANCHOR LIMIT, PART OF THE ANCHOR WAS LEFT OUT. THE ANCHOR WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20082236 ↗
• MalfunctionFeb 20, 2018Break

  IT WAS REPORTED THAT DURING A BANCART AND SLAP REPAIRING, AFTER DRILLING FIELD WITH 2,7 MM DRILL DEVICE LEAVED FROM THE GRIP. PATIENT BONE WAS HARD. ANCHOR WAS BROKEN AND ALL PIECES WERE REMOVED. OPERATION WAS COMPLETED WITH A TITANIUM ANCHOR BY PREPARING NEW HOLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7282937 ↗
• MalfunctionFeb 20, 2018Break

  IT WAS REPORTED THAT DURING A BANCART AND SLAP REPAIRING, AFTER DRILLING FIELD WITH 2,7 MM DRILL DEVICE LEAVED FROM THE GRIP. PATIENT BONE WAS HARD. ANCHOR WAS BROKEN AND ALL PIECES WERE REMOVED. OPERATION WAS COMPLETED WITH A TITANIUM ANCHOR BY PREPARING NEW HOLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7282934 ↗
• MalfunctionAug 25, 2017Break

  IT WAS REPORTED THAT DURING SHOULDER OPERATION, AREA WAS PREPARED WITH 2.9 MM DRILL. FIRST ANCHOR WAS PLACED APPROPRIATELY BUT SECOND ANCHOR TAP WAS BROKEN WHILE IT WAS BEING PLACED. ANCHOR WAS REMOVED FROM PATIENT AND NEW ANCHOR WAS PLACED BY PREPARING NEW HOLE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6822178 ↗
• MalfunctionApr 30, 2017Break

  IT WAS REPORTED THAT THE IMPLANT BROKE INSIDE THE JOINT. ALL PIECES WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE FOLLOWING A SHORT DELAY. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6533109 ↗
• MalfunctionMar 30, 2017Break

  IT WAS REPORTED THE BIORAPTOR 2.9 WITH 2 ULTRABRAID BROKE. A BACK UP DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6447672 ↗

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-0147-2021 · Sep 9, 2020 · Open, Classified
  RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805
• Z-0158-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 72202610
• Z-0143-2021 · Sep 9, 2020 · Open, Classified
  ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493
• Z-0175-2021 · Sep 9, 2020 · Open, Classified
  MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984
• 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-0140-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number: 7210713
• 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-0136-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309
• Z-0153-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996
• Z-0146-2021 · Sep 9, 2020 · Open, Classified
  BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702
• 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-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-0152-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995
• Z-0139-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Number: 7210712
• 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.