Rotation Medical Tendon Staples 2504Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00854501006067), received between Sep 9, 2019 and Jun 13, 2026 — classified as 28 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Break” (17 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 12, 2024Class IIOpen, Classified

   Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility

   Z-3096-2024 · Root cause: Packaging · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2026Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, EVERY TENDON ANCHOR BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25495661 ↗
• MalfunctionDec 8, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE TENDON ANCHORS 8 BROKE WHEN THEY WERE DEPLOYED. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH AN ARTERY. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744083 ↗
• MalfunctionOct 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF PROCEDURE, IN AN ATTEMPT TO AVOID WASTING THE REGENETEN IMPLANT, THE SURGEON TRIED TO STAPLE IT USING A TENDON ANCHOR; HOWEVER, THE IMPLANT WAS FIXATED OFF THE INTENDED REPAIR SITE AND THE SURGEON DECIDED TO REMOVE IT COMPLETELY. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23442200 ↗
• MalfunctionMay 14, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE TENDON ANCHORS HAD WATER DAMAGE TO THE BOX AND TO THE ACTUAL PRODUCT INSIDE OF THE PACKAGE. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019731 ↗
• InjuryOct 29, 2024Break; Break

  IT WAS REPORTED THAT DURING AN SHOULDER CUFF AUGMENTATION, BOX OF EIGHT (8) TENDON ANCHORS BROKE. THREE 3 BROKE DURING ASSEMBLY WHEN OPENING THE BOX, AND THE OTHER FIVE (5) IMPLANTS BROKE DURING APPLICATION INSIDE THE PATIENT. THE BROKEN IMPLANTS REMAINED INSIDE 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: Foreign Body In Patient

  MAUDE report 20561580 ↗
• MalfunctionAug 20, 2024Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TENDON ANCHORS (QUALITY HOLD ITEM) WERE USED IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

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

  MAUDE report 20005827 ↗
• MalfunctionJul 16, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING SET UP, A TENDON ANCHOR PUCK WAS NOT VACUUM SEALED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19747434 ↗
• MalfunctionJul 10, 2024Break; Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, SEVEN (7) TENDON ANCHORS BROKE WHEN TRYING TO RETRIEVE THEM FROM THE PUCK IT COMES IN AND THE REGENETEN PROCEDURE HAD TO BE ABANDONED. THE DEVICES DID NOT BREAK INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A BACK UP DEVICE INSTEAD. THERE WAS A SIGNIFICANT SURGICAL DELAY OF MORE THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19713529 ↗
• MalfunctionJul 1, 2024Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT, DURING SET UP, SEVEN TENDOR ANCHOR PUCKS WERE NOT VACUUM SEALED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19650346 ↗
• MalfunctionJul 1, 2024Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT, DURING SET UP, TWO TENDOR ANCHOR PUCKS WERE NOT VACUUM SEALED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19648597 ↗
• MalfunctionJun 27, 2024Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT (3) THREE TENDON ANCHORS' PACKAGES WERE NOT SEALED AND WERE PUNCTURED. THE EVENT OCCURRED AFTER REMOVING PACKAGING FROM OUTER BOX, FOR TREATMENT OF A PARTIAL ROTATOR CUFF TEAR. THE PROCEDURE WAS COMPLETED USING A BACKUP DEVICE WITH A DELAY OF LESS THAN 2 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19624859 ↗
• MalfunctionJun 27, 2024Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging

  IT WAS REPORTED THAT, TWO (2) TENDON ANCHORS WERE NOT VACUUMED SEALED COMPLETELY. THE AIR COULD NOT BE SQUEEZED OUT, IT WAS VACUUMED SEALED JUST NOT COMPLETELY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19624805 ↗
• MalfunctionMay 21, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT, DURING A SHOULDER RCR PROCEDURE, THREE (3) DIFFERENT LOTS OF TENDON ANCHORS COULD NOT BE LOADED IN THE INSERTION DEVICE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19360804 ↗
• MalfunctionMar 15, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, FIVE (5) OUT OF EIGHT (8) TENDON ANCHORS, BROKE AFTER BEING IMPLANTED USING THE TENDON STAPLE. ALL THE ANCHORS WERE REMOVED FROM THE PATIENT AS WELL AS THE REGENETEN PATCH. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 18918479 ↗
• 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 TENDON ANCHORS 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 18092780 ↗
• 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 TENDON 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 18048674 ↗
• 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 TENDON ANCHORS WERE 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 16950282 ↗
• InjuryApr 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FIVE WEEKS AFTER A DOUBLE ROW REPAIR ON A MASSIVE ROTATOR CUFF TEAR SURGERY, THE PATIENT EXPERIENCED INFLAMMATION AND DRAINING PORTALS. THE SURGEON ADMINISTERED ANTIBIOTICS FOR TWO DAYS BUT IT GOT WAY WORSE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY IN WHICH 40CC OF PUSS WAS DRAINED AND THE SUBACROMIAL SPACE WAS CLEANED OUT. DURING THIS SURGERY THE SURGEON SAW THE TENDON ANCHORS FLOATING INSIDE THE SUBACROMIAL SPACE AS WELL. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Inflammation; Medical device site infection

  MAUDE report 16773111 ↗
• InjuryFeb 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 4 MONTHS AFTER A SHOULDER PROCEDURE IN WHICH A REGENETEN DEVICE WAS IMPLANTED, THE PATIENT RETURN TO THE PHYSICIAN WITH STIFFNESS, PAIN AND POOR MOBILITY. THE PHYSICIAN DECIDED TO MRI THE PATIENT AND FROM THE IMAGING IT TURNED OUT THAT THE PATIENT HAD CALCIUM DEPOSITS IN THEIR SHOULDER, PATIENT WAS TREATED WITH AN INJECTION AFTERWARDS. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Calcium Deposits/Calcification; Muscular Rigidity; Pain

  MAUDE report 16440968 ↗
• InjuryFeb 23, 2023Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, FIVE (5) TENDON ANCHORS FRACTURED; 4 ANCHORS WHILE LOADING THEM INTO THE INSERTER AND 1 ANCHOR INSIDE OF THE PATIENT AND IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS FINISHED WITH 5 MINUTES OF DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16433464 ↗
• InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TENDON 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 16397257 ↗
• InjuryFeb 1, 2023Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN INSERTING THE PUCKS INTO THE TENDON, THE TENDON ANCHORS THEMSELVES WOULD BREAK. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, AND WHETHER IT CAUSED OR NOT A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16279454 ↗
• InjuryDec 21, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ACL, A TENDON ANCHOR DID NOT CLIP AND GOT BROKEN WHEN IMPLANTED TO THE PATCH. THE BROKEN ANCHOR WAS REMOVED WITH A GRASPER. SURGERY RESUMED AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16024705 ↗
• InjuryOct 14, 2022Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, SIX (6) TENDON ANCHORS BROKE WHILE UPLOADING AND IMPLEMENTATION. SURGERY WAS RESUMED WITH A BACK-UP DEVICE, BUT IT IS UNKNOWN WHETHER IT CAUSED A SURGICAL DELAY OR NOT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15611502 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED AN INFLAMMATION 6 WEEKS AFTER A SURGERY WHERE 2 REGENETEN DEVICES WERE USED. THE PATIENT WAS BROUGHT BACK TO SURGERY AT 8 WEEKS, NO INFECTION WAS FOUND BUT THE DOCTOR FELT THE REGENETEN WAS ¿MUSHY¿ AND DECIDED TO REMOVE IT. HE WAS NOT SURE IF THERE WAS AN ISSUE WITH REGENETEN, BUT HE IS ALSO NOT SURE IT WAS INCORPORATING LIKE IT SHOULD. FIXATION COULD HAVE ALSO BEEN AN ISSUE AS THE DISTAL PART OF THE IMPLANT MAY NOT HAVE BEEN FIXATED WELL. NO ADDITIONAL COMPLICATIONS WERE REPORTED.

  Patient problems: Inflammation

  MAUDE report 15577573 ↗