HEALICOIL REGENESORB 72203697Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00885554031393), received between Sep 12, 2017 and Nov 13, 2025 — classified as 19 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Break” (32 reports).

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 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2025Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPE, A HEALICOIL RSB ANCHOR BROKE ON INSERTION, DUE TO THE BONE BEING TOO HARD. ALL BROKEN PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT WITH A GRASPER. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT IN THE ORIGINALLY DRILLED BONE HOLE. NO VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544787 ↗
• MalfunctionOct 8, 2025Break; Break

  IT WAS REPORTED THAT, DURING A SURGERY, IT WAS NOTICED THAT ONE (1) HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL DISINTEGRATED AND THE SUTURES WERE SEVERED PRIOR TO PLACEMENT. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23251588 ↗
• MalfunctionSep 4, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE HEALICOIL ANCHOR BROKE ON INSERTION; THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING A GRASPER, THE SURGERY WAS COMPLETED USING A SMITH AND NEPHEW BACKUP DEVICE IN THE SAME HOLE, THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963551 ↗
• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ANCHOR OF THE HEALICOIL BROKE WHILE DEPLOYING. ALL THE PIECES WERE REMOVED FROM THE PATIENT USING TWEEZERS. IT IS UNKNOWN IF THERE WAS A DELAY AND A BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22700114 ↗
• MalfunctionJun 25, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE HEALICOIL GOT BROKEN WHILE PUTTING INTO THE BONE. 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 22328329 ↗
• MalfunctionMar 28, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE SURGEON SCREWED THE SUTURE OF ONE (1) HEALICOIL ANCHOR INSIDE THE BONE, THE ANCHOR GOT BROKEN, AND THE BROKEN PIECE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE USED. NO VOID WAS LEFT IN THE PATIENT, AND NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21719821 ↗
• MalfunctionDec 23, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE HEALICOIL ANCHOR BROKE WHILE BEING INSERTED INTO THE JOINT. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20999880 ↗
• MalfunctionNov 15, 2024Break; Crack; Break; Crack

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR SURGERY ON LEFT SHOULDER USING A DOUBLE ROW REPAIR METHOD, UPON THE INITIAL INSERTION AND TWISTING, THE HEALICOIL 4.75 WAS CRACKED AND THEN BROKE APART. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH THE HELP OF A GRASPER. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD, USED IN THE ORIGINALLY PUNCHED HOLE. 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 20700382 ↗
• MalfunctionSep 20, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE HEALICOIL ANCHOR CRACKED WHEN THE SURGEON INSERTED IT IN THE PILOT HOLE PREPARED BY THE 4.75 MM THREADED DILATOR; THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE IN THE SAME ORIGINALLY DRILLED BONE HOLE, NO VOID WAS LEFT IN THE PATIENT. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20273376 ↗
• MalfunctionMay 24, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE HEALICOIL ANCHOR GOT DAMAGED WHILE INSERTING AND SHATTERED INTO PIECES. THE PROCEDURE WAS COMPLETED USING A 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 19393495 ↗
• MalfunctionMar 21, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY, THE ANCHOR OF THE HEALICOIL BROKE OFF AT THE END WHEN IT WAS BEING PUT IN PLACE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. THE BACK UP WAS USED IN THE ORIGINALLY DRILLED HOLE. ALL THE PIECES WERE REMOVED FROM THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18952155 ↗
• MalfunctionMar 19, 2024Break; Break

  IT WAS REPORTED THAT DURING A SURGERY FOR ROTATOR CUFF TEAR, ACROMIOPLASTY AND TENOTOMY OF THE LEFT SHOULDER BICEPS, TWO HEALICOIL REGENESORB ANCHORS HAD DEFECTIVE SCREW THREADS PRIOR TO INSTALLATION. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18932497 ↗
• MalfunctionJan 25, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE HEALICOIL RSB ANCHOR TIP BROKE WHILE DEPLOYMENT, THE IMPLANT WAS SUCCESSFULLY REMOVED ARTHROSCOPICALLY USING GRASPERS. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18582092 ↗
• MalfunctionDec 26, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE HEALICOIL RSB ANCHOR WAS PULLED OUT DUE TO THE OSTEOPOROTIC BONE OF THE PATIENT AND THE DEVICE WAS USED AFTER ITS EXPIRATION DATE. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Osteopenia/ Osteoporosis

  MAUDE report 18395847 ↗
• MalfunctionDec 7, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE PACKAGE WAS OPENED, IT WAS NOTICED THAT ONE OF THE THREADS OF THE HELICOIL ANCHOR WAS FOUND TO BE BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY. IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE AVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18283849 ↗
• MalfunctionSep 18, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE HEALICOIL ANCHOR WAS BEING INSERTED INTO THE BONE IT BROKE. THE PROCEDURE WAS COMPLETED WITH 5 MINUTES DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17770519 ↗
• MalfunctionJul 25, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY BEFORE THE HEALICOIL ANCHOR WAS INSERTED INTO THE BONE HOLE, THE ANCHOR AND THE DISTAL TIP OF THE SHAFT WERE FOUND TO BE BENT WHEN CHECKED WITH AN IMAGE GENERATED BY THE CAMERA USED FOR ENDOSCOPIC SURGERY. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACKUP DEVICE, AND NO FURTHER COMPLICATIONS WERE REPORTED. PER PRELIMINARY RESULTS OF THE INVESTIGATION, IT WAS REVEALED THAT THE ANCHOR IS FRACTURED AT THE DISTAL END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17392655 ↗
• MalfunctionJun 29, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHILE THE SURGEON WAS TRYING TO SCREW IN THE ANCHOR, THE HEALICOIL BROKE, IT WAS REMOVED WITH THE HELP OF A GRASPER. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A NON-SIGNIFICANT SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED. THE BACK UP DEVICE WAS USED IN THE ORIGINAL BONE HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17225852 ↗
• MalfunctionMay 10, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, WHILE SCREWING THE HEALICOIL ANCHOR, THE ANCHOR BROKE. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH THE HELP OF A GRASPER AND TWEEZERS. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16901656 ↗
• InjuryNov 29, 2022Crack; Crack

  IT WAS REPORTED THAT DURING A MINI OPEN ROTATOR CUFF REPAIR, WHERE A GOLD 3.8 AWL WAS USED TO PREPARE THE BONE HOLE, AN HEALICOIL REGENESORB 4.5MM ANCHOR CRACKED UPON INSERTION. ALL THE REMNANTS OF THE ANCHOR AND THE SUTURES WERE REMOVED FROM THE PATIENT. SURGERY RESUMED AFTER A NON-SIGNIFICANT DELAY OF LESS THAN 2 MINUTES, WITH A BACK-UP ANCHOR WHERE A 4.75 HEALICOIL DILATOR WAS USED PRIOR THE INSERTION, WHICH SEEMED TO NOT BE USED WITH THE FIRST ANCHOR THAT CRACKED. NO ADVERSE OUTCOMES FOR THE PATIENT WERE REPORTED, AS WELL AS NO FURTHER DETAILS ARE AVAILABLE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15876142 ↗
• InjurySep 30, 2022Crack; Crack

  IT WAS REPORTED THAT DURING AN ARCR PROCEDURE, THE HEALICOIL ANCHOR CRACKED WHEN IT WAS BEING INSERTED INTO THE BONE HOLE. ALL THE PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15509399 ↗
• InjuryJul 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, WHEN THE 4.75MM HEALICOIL REGENESORB SUTURE ANCHOR WAS INSERTED INTO THE BONE HOLE, THE SUTURE AND TAPE CAME OFF THE ANCHOR. THE ANCHOR COULD NOT BE REMOVED FROM THE BODY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED PLACING A BACK-UP DEVICE INTO AN ADDITIONAL DRILLED BONE HOLE. THERE WAS A NON-SIGNIFICANT SURGICAL DELAY OF 10MIN, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Rupture

  MAUDE report 15136065 ↗
• InjuryJun 27, 2022Difficult to Insert; Nonstandard Device; Difficult to Insert; Nonstandard Device

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, IT WAS NOTICED THAT THE HEALICOIL REGENESORB WIRE WAS TOO THIN IN PLACES AND DID NOT PASS THROUGH THE CUFF AUTOMATICALLY WITH THE TWEEZER, DUE TO THIS EVENT AN ADDITIONAL BONE HOLE WAS REQUIRED. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE IN THE ADDITIONAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Rupture

  MAUDE report 14830900 ↗
• InjuryJun 13, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE HEALICOIL ANCHOR BROKE WHILE BEING INSERTED INTO THE PILOT HOLE PREPARED. THE PIECES OF THE BROKEN ANCHOR WERE REMOVED WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE . NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14675901 ↗
• InjuryMay 23, 2022Break; Break

  IT WAS REPORTED THAT DURING USE IN AN UNSPECIFIED PROCEDURE, THE HEALICOIL ANCHOR WAS IMPLANTED SUCCESSFULLY AND AS THE INSERTER WAS REMOVED THERE WERE SEVERAL METAL SHAVINGS THAT COULD BE SEEN THROUGH THE SCOPE. THE METAL SHAVINGS WERE REMOVED WITH AN ARTHROSCOPIC SHAVER. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE OR HOW THE ISSUE WAS RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14474372 ↗