HEALICOIL / ULTRABRAID 72203707Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00885554030860), received between Jan 20, 2018 and Mar 31, 2026 — classified as 17 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Break” (26 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 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Break

  IT WAS REPORTED THAT, DURING SURGERY, ONE (1) HEALICOIL SUTURE ANCHOR BROKE AND THE METAL TIP WENT INTO THE SHOULDER WITH THE ANCHOR. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED AND IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747529 ↗
• MalfunctionMar 26, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, TWO (2) HEALICOIL ANCHORS BROKE WHILE SCREWING IN AFTER TAPPING. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21694900 ↗
• MalfunctionFeb 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE HEALICOIL ANCHOR SPLIT IN HALF. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21410531 ↗
• MalfunctionJan 21, 2025Failure to Cycle; Failure to Cycle

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, AS THE SURGEON ROTATED THE HANDLE TO DESCEND THE INTERNAL PLUG, IT WAS NOTICED THAT THE HEALICOIL ANCHOR DID NOT ROTATE WITH THE HANDLE, RESULTING IN THE ANCHOR NOT BEING FULLY IMPLANTED. THE ANCHOR WAS REMOVED FROM THE PATIENT WITH A GRASPER. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21204222 ↗
• MalfunctionAug 27, 2024Break; Separation Failure; Break; Separation Failure

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE HEALICOIL DID NOT DEPLOY AND BROKE OUT WHILE SCREWING IN THE HUMERUS HEAD. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20082440 ↗
• MalfunctionAug 7, 2024Break; Break

  IT WAS REPORTED THAT DURING A AN ARTHROSCOPY, THE HEALICOIL SA 5.5MM ANCHOR CRACKED NOTICEABLY AFTER THE FIRST TURN. THE PIECES WERE REMOVED USING A GRASPER. THE BONE HOLE WAS TAPPED AND S+N BACK UP DEVICE WAS PLACED INTO AN ADDITIONAL BONE HOLE. THERE WAS A SURGICAL DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 19927931 ↗
• InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS AFTER AN ARCR PROCEDURE PERFORMED ON (B)(6) 2023, WHERE A HEALICOIL RG ANCHOR WAS USED; THE PATIENT EXPERIENCED SEVERAL ADVERSE EVENTS. AN MRI WAS PERFORMED, SYNOVITIS AND RICE GRAIN-LIKE LESIONS APPEARED. THE RICE BODIES WERE IDENTIFIED ABOUT SIX MONTHS AFTER A SURGERY ((B)(6) 2024). FURTHERMORE, THE PATIENT HAD PAIN AND SWELLING. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Foreign Body Reaction; Swelling/ Edema; Synovitis

  MAUDE report 19813387 ↗
• InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS AFTER AN ARCR PROCEDURE PERFORMED ON (B)(6) 2023, WHERE A HEALICOIL RG ANCHORS WAS USED; THE PATIENT EXPERIENCED SEVERAL ADVERSE EVENTS. AN MRI WAS PERFORMED, SYNOVITIS AND RICE GRAIN-LIKE LESIONS APPEARED. THE RICE BODIES WERE IDENTIFIED ABOUT SIX MONTHS AFTER A SURGERY ((B)(6) 2024). FURTHERMORE, THE PATIENT HAD PAIN AND SWELLING. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Foreign Body Reaction; Swelling/ Edema; Synovitis

  MAUDE report 19813380 ↗
• InjuryJul 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS AFTER AN ARCR PROCEDURE PERFORMED ON (B)(6) 2023, WHERE A HEALICOIL RG ANCHOR WAS USED; THE PATIENT EXPERIENCED SEVERAL ADVERSE EVENTS. AN MRI WAS PERFORMED, SYNOVITIS AND RICE GRAIN-LIKE LESIONS APPEARED. THE RICE BODIES WERE IDENTIFIED ABOUT SIX MONTHS AFTER A SURGERY ((B)(6) 2024). FURTHERMORE, THE PATIENT HAD PAIN AND SWELLING. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Foreign Body Reaction; Swelling/ Edema; Synovitis

  MAUDE report 19813376 ↗
• MalfunctionJul 11, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE HEALICOIL ANCHOR WAS INSERTED, THE FIRST THREAD OF THE ANCHOR BODY BROKE. THE BROKEN IMPLANT WAS PULLED OUT FROM THE PATIENT'S BODY. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION OF THE ANCHOR, AND THE BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE. NO VOID LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19727372 ↗
• InjuryJul 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE EYELET WHERE THE SUTURE WAS ATTACHED ON THE HEALICOIL 5.5MM ANCHOR BROKE, CAUSING THE SUTURE TO FALL OUT. THE ANCHOR´S BODY REMAINS SECURE INSIDE THE PATIENT BONE. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE INTO AN ADDITIONAL BONE HOLE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED. THE STATUS OF THE PATIENT WAS NORMAL.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 19714245 ↗
• MalfunctionJul 10, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE HEALICOIL 5.5MM ANCHOR´S BODY FRACTURE WHEN IT WAS BEING INSERTED. THE BROKEN FRAGMENTS WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19714172 ↗
• MalfunctionJun 21, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE ANCHOR OF THE HEALICOIL WAS INSERTED, THE IMPLANT BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19580636 ↗
• MalfunctionJun 21, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE ANCHOR OF THE HEALICOIL WAS INSERTED, THE IMPLANT BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19580486 ↗
• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN ARCR PROCEDURE, WHEN TWO (2) HEALICOIL ANCHORS WERE INSERTED INTO THE BURSA, FRAGMENTS OF THE ANCHORS FELL OFF. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A 10 MINUTE SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838335 ↗
• InjuryNov 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPY, THE HEALICOIL RG ANCHOR AND TAPPER WERE SUCCESSFULLY INSERTED; HOWEVER, THE THREAD BECAME DETACHED FROM THE IMPLANT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18229683 ↗
• MalfunctionNov 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE HEALICOIL ANCHOR FRACTURED DURING THE INSERTION. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18211644 ↗
• MalfunctionNov 27, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE HEALICOIL ANCHOR BROKE DURING THE INSERTION, EVEN WITHOUT APPLYING FORCE. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18211476 ↗
• MalfunctionNov 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE HEALICOIL ANCHOR FRACTURED DURING THE INSERTION, EVEN WITHOUT APPLYING FORCE. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18211280 ↗
• MalfunctionNov 27, 2023Break; Break

  IT WAS REPORTED THAT DURING SET UP, WHEN THE BOX WAS OPENED FOR THE FIRST TIME, IT WAS NOTICED THAT THE FRONT OF THE HEALICOIL IMPLANT WAS BROKEN. THERE WAS A BACK-UP DEVICE AVAILABLE AND A SURGICAL DELAY LESS THAN 30 MINUTES WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209649 ↗
• MalfunctionSep 25, 2023Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, AFTER INSERTING THE SECOND ANCHOR OF THE HEALICOIL REGENERSORB, A FEW PIECES OF IT WERE FLOATING IN THE JOINT, THE PIECES WERE TAKEN OUT WITH A GRASPER. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE IN THE SAME BONE HOLE BUT AN UNTAPERED AWL WAS USED TO WIDEN THE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17810208 ↗
• MalfunctionSep 12, 2023Crack; Crack

  IT WAS REPORTED THAT DURING AN RCR PROCEDURE, WHEN PREPARING THE HOLES FOR THE HEALICOIL REGENERSORB ANCHORS IT WAS NOTED FROM ASSISTANT THAT THE BONE WAS QUITE HARD. SURGEON USED THE WIDER SILVER AWL FOR THE FIRST ANCHOR WHICH HAD NO ISSUES. WITH THE SECOND ANCHOR HE DECIDED TO ONLY USE THE TAPERED GOLD AWL., WHEN ENTERING THIS ANCHOR, THE BASE CRACKED SLIGHTLY AS THE BONE WAS TOO HARD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE IN THE ORIGINAL DRILLED BONE HOLE BUT IT WAS MADE WIDER WITH UNTAMPERED AWL. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17733009 ↗
• MalfunctionAug 3, 2023Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF, AN HEALICOIL´S ANCHOR TIP SNAPPED OFF WHEN INSERTED INTO THE BONE, ALTHOUGH CORRECT SURGICAL TECHNIQUE WAS FOLLOWED TO CREATE THE INSERTION HOLE; WHICH WAS PREPARED WITH A SILVER/GOLD AWL AND APPROPRIATE DILATATOR TAP. THE HEALICOIL´S ANCHOR TIP WAS REMOVED FROM THE PATIENT. PATIENT´S BONE QUALITY WAS INCREDIBLY HARD; THEREFORE THE SURGERY RESUMED AFTER A NON-SIGNIFICANT DELAY WITH A SUPPLEMENTARY BACK-UP PEEK ANCHOR IN PLACE OF THE REGENESORB MATERIAL, IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17454188 ↗
• MalfunctionJul 20, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, TWO (2) HEALICOIL GOT TORN. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING THE SAME DEVICES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17360430 ↗
• InjuryMar 26, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON 22-NOV-2020 A LEFT SHOULDER ROTATOR CUFF REPAIR, DISTAL CLAVICLE EXCISION, EXTENSIVE DEBRIDEMENT, BICEPS TENODESIS, AND SUBACROMIAL DECOMPRESSION WERE PERFORMED, WHERE A HEALICOIL WAS PLACED. IN DECEMBER 2022, THE PATIENT FELT A POP WHEN DOING THERAPY AND DEVELOPED SEVERE PAIN AND NOTICED THAT HIS BICEP HAD SUNKEN INTO HIS ARM. ON JANUARY 19, A REVISION SURGERY WAS PERFORMED AND IT WAS DISCOVERED THAT THE SMITH & NEPHEW ANCHOR(S) FAILED, WHICH CAUSED A HIGH-GRADE CUFF TEAR AMONG OTHER SERIOUS COMPLICATIONS. SURGEON REMOVED THE FAILED HARDWARE AND PLACED TWO Q-FIX IMPLANTS. AN EXTENSIVE DEBRIDEMENT OF THE SCAR TISSUE WHERE HE HAD STIFFNESS WAS MADE. THE CENTRAL ASPECT OF THE MEDIAL ROW ANCHOR HAD PULLED OUT AND A BROKEN CUFF ANCHOR HAD TO BE REMOVED, AS WELL AS THE LOOSE ANCHOR DEBRIS. THEN, AN ADDITIONAL LATERAL ROW ANCHOR FOR ADDITIONAL FOOTPRINT COVERAGE AND STABILITY WAS PLACED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Muscle/Tendon Damage; Scar Tissue

  MAUDE report 16616744 ↗

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-0165-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290
• Z-0174-2021 · Sep 9, 2020 · Open, Classified
  MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204983
• Z-0161-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620
• Z-0154-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165
• Z-0166-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Number: 72203291
• 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-0153-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996
• 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-0157-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Number: 72202608
• Z-0152-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995
• Z-0138-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711
• Z-0149-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992
• Z-0147-2021 · Sep 9, 2020 · Open, Classified
  RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805
• Z-0151-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994
• Z-0143-2021 · Sep 9, 2020 · Open, Classified
  ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493

…and 25 more.