HEALICOIL 72203981Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00885554032123), received between Aug 18, 2017 and Sep 25, 2023 — classified as 8 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2023Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE THREADS OF THE HEALICOIL ANCHORS PEELED ON INSERTION INTO THE HUMERAL HEAD, THERE WAS SEPARATION OF THE THREADS FROM THE CORE ANCHOR. ALL THE ANCHOR MATERIAL WAS REMOVED FROM THE PATIENT WITH THE HELP OF FORCEPS. NON-SIGNIFICANT SURGICAL DELAY WAS REPORTED, AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE USED IN THE ORIGINALLY DRILLED BONE HOLE, NO VOID LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17807511 ↗
• MalfunctionSep 25, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE THREADS OF THE HEALICOIL ANCHORS PEELED ON INSERTION INTO THE HUMERAL HEAD, THERE WAS SEPARATION OF THE THREADS FROM THE CORE ANCHOR. ALL THE ANCHOR MATERIAL WAS REMOVED FROM THE PATIENT WITH THE HELP OF FORCEPS. NON-SIGNIFICANT SURGICAL DELAY WAS REPORTED, AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE USED IN THE ORIGINALLY DRILLED BONE HOLE, NO VOID LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17807487 ↗
• InjuryDec 6, 2021Break; Break

  IT WAS REPORTED THAT DURING USE OF INSTRUMENTS INSIDE THE PATIENT IN A ROTATOR CUFF REPAIR, THE HEALICOIL ANCHOR FAILED ON DEPLOYMENT AND THE THREADS PEELED AND FRACTURED AWAY FROM THE CENTER CORE UPON INSERTION. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. NON-SIGNIFICANT DELAY WAS REPORTED, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12936918 ↗
• InjuryJun 28, 2021Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT DURING A SURGERY THE HEALICOIL ANCHOR THREADS PEELED ON CORTEX AT INSERTION, AFTER FOLLOWING THE SURGICAL INSERTION TECHNIQUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12075055 ↗
• InjuryJun 27, 2021Break; Break

  IT WAS REPORTED THAT THE HEALICOIL ANCHOR THREAD PEELED ON THE CORTEX AT INITIAL INSERTION AFTER FOLLOWING SURGICAL INSERTION TECHNIQUE DURING THE SHOULDER ARTHROSCOPY. THE STANDARD HEALICOIL PUNCH WAS USED TO PREPARE THE INSERTION SITE (3.8MM). ANCHOR WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACKUP DEVICE. THERE WAS NO SIGNIFICANT DELAY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12073139 ↗
• InjuryNov 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY, THE 4.5 HEALICOIL PULLED OUT FROM THE SOFT BONE. NO SIGNIFICANT DELAY OR PATIENT INJURIES WERE REPORTED. SURGERY WAS COMPLETED USING A 5.5 HEALICOIL. NO ADDITIONAL BONE HOLE WAS REQUIRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10853709 ↗
• InjurySep 25, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE HEALICOIL ANCHOR WAS PULLED OUT AFTER THE SUTURE WAS TIED DOWN, ALL PIECES WERE REMOVED USING GRASPERS; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A USING A BACK-UP DEVICE IN A NEW BONE HOLE; NO 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 Information; Rupture

  MAUDE report 10585936 ↗
• InjurySep 20, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE DURING SHOULDER SCOPE RTC REPAIR PROCEDURE, THE ANCHOR WAS PULLED OUT AFTER THE SUTURE WAS TIED DOWN. A NEW BONE HOLE WAS REQUIRED TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO 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 Information

  MAUDE report 10558145 ↗
• InjuryJul 20, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE TIP OF THE HEALICOIL ANCHOR CAME APART FROM THE REST OF THE ANCHOR BODY. THE HOLE WAS PUNCHED TO THE CORRECT DEPTH AND THE ANGLE OF INSERTION WAS INLINE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY 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 Known Impact Or Consequence To Patient

  MAUDE report 10300055 ↗
• InjuryJul 15, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE "4.5MM HELICOIL PEEK ANCHOR" TORN OFF AFTER IMPLANTATION. IN CONSEQUENCE, THE ANCHOR WAS REMOVED FROM THE PATIENT. THE PROCEDURES WERE SUCCESSFULLY COMPLETED USING A MULTIFIX ANCHOR AS BACK-UP DEVICE INTO AN ADDITIONAL BONE HOLE. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES AND NO 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 Information

  MAUDE report 10281055 ↗
• MalfunctionJul 14, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE "4.5MM HELICOIL PEEK ANCHOR" TORN OFF AFTER IMPLANTATION. IN CONSEQUENCE, THE ANCHOR WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A MULTIFIX ANCHOR AS BACK-UP DEVICE INTO AN ADDITIONAL BONE HOLE. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES (ONE HOUR) AND NO 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 Information

  MAUDE report 10273911 ↗
• MalfunctionApr 21, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR THE DISTAL TIP OF THE HEALICOIL PK INSERTER CAME OFF AFTER ANCHOR INSERTION. A FEW MILLIMETERS WERE STICKING OUT OF THE BONE, WHICH HELP THE SURGEON TO GET A GOOD GRIP WITH ARTHROSCOPIC GRASPERS AND PULLED THE TIP OUT. SURGEON REPORTED HARD BONE-BONE PREP WAS DONE ACCORDING TO SURGICAL TECHNIQUE AND ANCHOR INSERTION SEEMED AS EXPECTED. THE PROCEDURE HAD A DELAY SHORTER THAN 30 MINUTES AND IT WAS COMPLETED WITH A BACK UP DEVICE. NO INJURY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9984299 ↗
• MalfunctionJun 12, 2019Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT UPON INSERTION THE ANCHOR SHREDDED IT'S THREAD. AFTER WHICH THE SURGEON DETERMINED THAT THE BONE QUALITY WAS VERY HARD AND POSSIBLY THE ISSUE CAUSE. THEY USED A THREADED TAP FOR THE SECOND ANCHOR AND HAD NO ISSUES. THE BIGGEST CONCERN WAS THE FRAGMENTS OF PEEK LEFT BEHIND ON THIS ANCHOR, WHICH THE SURGEON CLEANED UP. NO PATIENT INJURY OR SIGNIFICANT DELAY WERE REPORTED. NO ADDITIONAL BONE HOLE WAS NECESSARY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8690869 ↗
• MalfunctionAug 29, 2018Detachment of Device or Device Component

  IT WAS REPORTED THAT UPON INSERTION THE THREADS ON THE ANCHOR CAME OFF INSIDE THE PILOT HOLE. THE ANCHOR ITSELF CAME OUT EASILY WITHOUT THE THREADS. IT IS UNKNOWN IF THERE WAS A DELAY OR A BACK UP AVAILABLE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7828946 ↗
• MalfunctionNov 21, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE SUTURE WAS TRAPPED AND WOULD NOT SLIDE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7051307 ↗
• MalfunctionOct 2, 2017Hole In Material

  IT WAS REPORTED THAT ULTRATAPE WAS PIERCED THROUGH ITSELF WHEN THE HEALICOIL WAS DEPLOYED AND DISENGAGED FROM INSERTER. THIS PATIENT HAD TO HAVE ONE EXTRA BONE HOLE MADE BECAUSE OF THE FAILED ANCHOR.

  Patient problems: No Code Available

  MAUDE report 6906874 ↗
• MalfunctionOct 2, 2017Hole In Material

  IT WAS REPORTED THAT ULTRATAPE WAS PIERCED THROUGH ITSELF WHEN THE HEALICOIL WAS DEPLOYED AND DISENGAGED FROM INSERTER. THIS HAPPENED IN BACK TO BACK ANCHORS IN THE SAME CASE. THIS PATIENT HAD TO HAVE ONE EXTRA BONE HOLE MADE BECAUSE OF THE FAILED ANCHOR.

  Patient problems: No Code Available

  MAUDE report 6906845 ↗
• MalfunctionAug 18, 2017Break

  IT WAS REPORTED THAT DURING THE PROCEDURE THE ANCHOR BROKE ON INSERTION. IT WAS REMOVED FROM THE PATIENT. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6805884 ↗