Bone Anchors with Arthroscopic Delivery System - Advanced 4403Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00854501006159), received between Jun 3, 2020 and Nov 18, 2025 — classified as 19 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2025Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, ONE RETRACTABLE PRONG OF A TENDON ANCHOR INSERTER BROKE OFF. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23581598 ↗
• MalfunctionNov 4, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR SURGERY, WHEN CREATING THE BONE HOLES FOR THE FIXATION OF THE REGENETEN IMPLANT, THE PRONGS OF ONE (1) BONE PUNCH BUCKLED AND BENT ON THE SECOND TAP WITH THE MALLET. THE SURGEON TRIED TO BEND IT BACK INTO PLACE BUT BECAUSE OF THE POTENTIAL RISK OF SNAPPING INSIDE THE PATIENT'S BONE, THEY OPENED A NEW DEVICE. THE SURGEON HAD TO CREATE AND USE SEPARATE HOLES TO PLACE THE NEXT BONE ANCHOR. THE REGENETEN IMPLANT WAS SUCCESSFULLY PLACED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23464154 ↗
• MalfunctionDec 20, 2024Break; Break

  IT WAS REPORTED THAT DURING A CUFF REPAIR, AFTER NUMEROUS ATTEMPTS TO SECURE THE REGENETEN OVER THE TENDON REPAIR, ONE OF THE INNER METAL ARMS THAT HOLD THE TENDON ANCHOR STAPLE BROKE OFF INTO THE REGENETEN IMPLANT. THIS METAL FRAGMENT WAS RETRIEVED SUCCESSFULLY AND REMOVED FROM THE PATIENT WITH GRASPERS. AFTER OPENING 2 TENDON PUCKS AND AN ADDITIONAL SET OF BONE ANCHORS WITH THE SAME LOT NUMBER, IT WAS DETERMINED THAT THE STAPLERS WERE THE ISSUE, THE SURGEON ABANDONED THE REGENETEN AUGMENT AND REMOVED THE PATCH AND ANY FREE TENDON ANCHOR FROM THE PATIENT AND ABANDON IMPLANTING THE REGENETEN DUE TO STAPLES MISFIRING. THE PROCEDURE WAS COMPLETED WITH A CHANGE IN THE SURGICAL TECHNIQUE THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20990059 ↗
• MalfunctionJun 24, 2024Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE INNER PRONG OF THE TENDON ANCHOR INSERTER, BROKE OFF ON THE MEDIAL SIDE OF THE IMPLANT AND ROTATOR CUFF TENDON UPON USE, IT WAS WELL PLACED AND NOT IN A POSITION THAT IT COULD HIT THE BONE. THE PRONG WAS LEFT HANGING IN THE ROTATOR CUFF TISSUE AND INSIDE THE REGENETEN IMPLANT. IT WAS EASILY FULLY REMOVED WITH A GRASPER AND NOTHING WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS A DELAY OF 3 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19594066 ↗
• InjuryJan 30, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY, THE BONE ANCHORS WERE USED TO PIN DOWN THE REGENETEN IMPLANT BUT THE ANCHOR BROKE INTO 2 UPON IMPLANTATION. THE BROKEN ANCHOR COULD NOT BE FOUND AS IT DISLODGED INTO THE JOINT SPACE. A SMALL VOID WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE IN A NEW LOCATION. THERE WAS A DELAY LESS THAN 30 MINUTES. AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient; Perforation

  MAUDE report 18610389 ↗
• MalfunctionDec 28, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR SURGERY, THE TENDON ANCHOR INSERTER WAS USED ONCE SUCCESSFULLY, BUT WAS POSSIBLY BENT WHILE IN USE. ALSO, THE INSERTER BROKE TWO PLLA ANCHORS, AND IT WAS NOT USED ANY LONGER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18414871 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT ACHILLES TENDON ENDOSCOPIC DEBRIDEMENT, EXCISION OF HAGLUND¿S LESION AND REGENETEN OPERATION WHERE A BIOINDUCTIVE IMPLANT (B)(4), TENDON ANCHORS (B)(4) AND BONE ANCHORS (B)(4) WERE USED, THE PATIENT HAD SERIOUS DISCHARGE OVER THE WOUND, EVEN AFTER THE WOUNDS WERE HEALED AND STO WAS DONE. A CULTURE WAS TAKING FROM THE WOUND AND IT WAS NEGATIVE FOR ANY HARMFUL PATHOGEN. WHEN THE DISCHARGE WAS NOTICED, THE PATIENT WAS PROVIDED WITH ORAL AUGMENTIN, BUT THE PATIENT COULD NOT TOLERATE IT AND THIS LET TO VOMITING. THEREFORE, THE PATIENT WAS ADMINISTER 3 DAYS OF IV AND 5 DAYS OF ORAL TREATMENT. AFTER 3 WEEKS THE WOUND HAD DRIED UP, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 18092889 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A REGENETEN IMPLANTATION PROCEDURE USING THE BONE ANCHORS IN 2022, THE PATIENT HAD RICE BODIES AND EXPERIENCED PAIN, A WASHOUT WAS PERFORMED ON (B)(6) 2023. THE CURRENT PATIENT STATUS IMPROVED SINCE WASHOUT.

  Patient problems: Foreign Body Reaction; Pain; Synovitis

  MAUDE report 18048624 ↗
• MalfunctionOct 3, 2023Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE BONE ANCHOR BROKE. X-RAY VIA FLUOROSCOPY WAS USED TO TRY TO LOCATE THE BROKEN PIECE. IT WAS VISUALIZED WITH THE SCOPE AND RETRIEVED. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17864960 ↗
• InjuryMay 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, APPROXIMATELY, A MONTH AND HALF AFTER AN ARTHROSCOPY WHERE BONE ANCHORS WAS USED, A RAISED SACK APPEARED ON THE INTRA LATERAL PORTAL OF THE PATIENT. SYNOVIAL FLUID WAS DRAINING OUT OF THE SACK WITH SOME CHUNKS. WHEN THE SACK WAS DECOMPRESSED AND THEN ABDUCTED, PARTICLES COULD BE SEEN. IT IS UNKNOWN HOW THE INJURY WAS TREATED OR THE PATIENT'S OUTCOME.

  Patient problems: Fluid Discharge; Swelling/ Edema

  MAUDE report 16949979 ↗
• InjuryApr 28, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE USING REGENETEN, THE SURGEON WANTED TO PLACE THE TENDON ANCHOR TO SECURE THE REGENETEN PATCH, BUT FAILED TO SUCCESSFULLY SLOT IN THE TENDON ANCHORS IN THE INSERTER. AT THE BEGINNING IT WAS SMOOTH BUT AFTER MULTIPLE TIMES OF SLOTTING IN THE TENDON ANCHORS IN THE INSERTER, IT WAS OBSERVED THAT THE TENDON ANCHOR ARMS WERE TORE IN THE CONTAINER WHILE TRYING TO SLOT IN WITH THE INSERTER. NO BROKEN PIECES REMAIN INSIDE THE PATIENT. THE PROCEDURE WITH REGENETEN DEVICE WAS CANCELLED AND IT WAS CLOSED BY DOING DEBRIDEMENT. THERE WAS A DELAY WITHIN 30 MINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16838339 ↗
• InjuryFeb 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BONE ANCHOR GENERATED AN ADVERSE REACTION, AND CAUSED AN INFLAMMATORY RESPONSE WHEN USING IT. THE DEVICE WAS EXPLANTED THE SAME DAY. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Inflammation

  MAUDE report 16388409 ↗
• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN ARTHROSCOPY WITH REGENETEN BONE ANCHORS, A PATIENT PRESENTED CELLULITIS OF RIGHT UPPER EXTREMITIES. THE ISSUE WAS RESOLVED WITH MEDICATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Cellulitis

  MAUDE report 15535521 ↗
• InjurySep 20, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, IT WAS NOTED THAT THE BONE ANCHORS WITH ARTHROSCOPIC DELIVERY TIP WAS BROKEN, AND UNABLE TO FIND THE BROKEN PIECE. A PORTABLE X-RAY WAS DONE. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15457764 ↗
• InjuryJul 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A ROTATOR CUFF REPAIR PROCEDURE HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED SOME STIFFNESS. DURING THAT CASE THE SURGEON BELIEVED THAT THE TIP OF THE REGENETEN BONE ANCHOR INSERTER MIGHT HAVE BROKEN, SURGEON CHANGED TO OPEN REPAIR A USED FLUOROSCOPY TO CONFIRM THAT NOTHING WAS LEFT BEHIND. THE PATIENT CAME BACK WITH AN X-RAY FROM AN OUTSIDE IMAGINING FACILITY AND IT SHOWED SOME ARTIFACTS THAT COULD NOT BE MADE OUT, BUT THE SURGEON BELIEVED THAT THIS WAS DUE TO THE PATIENT WEARING A SHIRT, AND NOT BECAUSE OF THE INSERTER. THE CURRENT HEALTH STATUS OF THE PATIENT IS STABLE.

  Patient problems: Loss of Range of Motion

  MAUDE report 15001846 ↗
• InjuryJan 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TWO YEARS OF A ROTATOR CUFF REPAIR USING 'TENDON ANCHORS, BONE ANCHORS AND THE BIOINDUCTIVE IMPLANT', A REVISION SURGERY WAS PERFORMED TO GRAB IMPLANT BECAUSE IT DIDN'T WORK PROPERLY IN THE BONE. THE PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13361294 ↗
• InjuryDec 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THREE HEALICOIL ANCHORS, ONE FIRSTPASS, ONE BONE ANCHOR, ONE TENDON ANCHOR, AND ONE BIOINDUCTIVE IMPLANT WERE USED ON A SHOULDER ROTATOR CUFF REPAIR. AFTER PROCEDURE IT WAS NOTICED THAT THE PATIENT GOT AN INFECTION. A REVISION SURGERY WAS REQUIRED FOR WASH OUT THE INFECTION. THE PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 13060708 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THREE MONTHS OF AN ACHILLES REATTACHMENT PROCEDURE WITH FOUR SUTURE ANCHORS; FROM ANOTHER UNKNOWN VENDOR; AND RENEGETEN BIOINDUCTIVE IMPLANT WITH TENDON AND BONE ANCHORS, THE PATIENT WAS STILL SWOLLEN AND WITH SOME PAIN. A SECOND SURGERY WAS PERFORMED AFTER 5 MONTHS OF THE PROCEDURE AND THERE WAS NO VISIBLE INFECTION. THE REGENETEN IMPLANT WAS REMOVED, TISSUE WAS EVALUATED AND DEEMED NO FURTHER REPAIR WAS NECESSARY. THE PATIENT IS DOING WELL.

  Patient problems: Inflammation; Pain

  MAUDE report 12907458 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON A PATIENT WERE PREVIOUSLY BONE ANCHORS WERE USED. A GRANULOMA CYST AND A LARGE BONE VOID WERE IDENTIFIED AT THE PROCEDURE. CULTURES WERE TAKEN. CURRENT STATUS OF THE PATIENT AND HOW THE ISSUE WAS RESOLVED IS UNKNOWN.

  Patient problems: Granuloma; Rupture

  MAUDE report 12531223 ↗
• MalfunctionJul 19, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING USE IN AN ARTHROSCOPY, WHEN THE TENDON ANCHOR WAS LOADED INTO THE INSERTER, IT CUT THE ANCHOR INTO TWO PIECES. A DELAY GREATER THAN 30 MINUTES WAS REPORTED AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12191237 ↗
• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, APPROX.. 6 MONTHS POST-OPERATION, THE PATIENT RETURNED TO THE CLINIC REPORTING PAIN AND INFLAMMATION. THE PATIENT SAID A MATTRESS HOT HIS SHOULDER. THE MRIS SHOWED INFLAMMATION AND THE PRESENCE OF RICE BODIES AROUND THE REPAIR SITE. A RECENT MRI LOOKED GOOD AND NORMAL, RICE BODIES AND INFLAMMATION WERE GONE. PATIENT HAD AN INFECTION AND RECOVERED FOLLOWING ANTIBIOTICS. NO FOLLOW-UP SURGERY/WASHOUT WAS SCHEDULED.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 11826861 ↗
• InjurySep 11, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A REVISION RCR USING REGENETEN IMPLANT THE NURSE HAVE DIFFICULTY CAPTURING TENDON ANCHORS FROM PUCK. ON THE RETRIVAL 3 TENDON ANCHORS BROKE WHILE TRYING TO LOAD THEM. THE ANCHORS SNAPPED BEFORE BEING REMOVED FROM THE PUCK. THE DISTAL TIP OF INSERTER WAS SLIGHTLY SKEWED AFTER INITIAL USE. THEN A SECOND BONE ANCHOR WAS OPENED TO SPARE THE TENDON ANCHOR PUCK, IT WAS USED A NEW INSERTER AND THE TENDOR ANCHORS BROKE AGAIN WHEN LOADING. THE SURGEON USE THE REMAINING ANCHORS 1-2 SHORT OF HIS PREFERENCE, AND THE NEEDLE AND SUTURE IN ORDER TO FINISH SECURING THE IMPLANT. A DELAY OF 5 MINUTES WERE REPORTED. 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 10524489 ↗
• InjurySep 10, 2020Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR WITH REGENETEN, THREE BONE ANCHORS SEEMED TO NOT LINE UP WITH THE PUNCH, CAUSING THE IMPLANTS TO BROKE DURING INSERTION. ALL PIECES WERE REMOVED FROM THE PATIENT WITH A GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE IN A DIFFERENT SPOT. 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 10514740 ↗
• InjurySep 10, 2020Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR WITH REGENETEN, THREE BONE ANCHORS SEEMED TO NOT LINE UP WITH THE PUNCH, CAUSING THE IMPLANTS TO BROKE DURING INSERTION. ALL PIECES WERE REMOVED FROM THE PATIENT WITH A GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE IN A DIFFERENT SPOT. 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 10514700 ↗
• InjuryAug 25, 2020Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE BONE ANCHOR BROKE. THE PIECE WAS NOT REMOVED FROM THE PATIENT. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY AND NO PATIENT INJURIES 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 10452136 ↗