DYNOMITE 72201881Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 03596010619068), received between Jan 4, 2018 and May 19, 2026 — classified as 9 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Fracture

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, ONE (1) DYNOMITE ULTRABRAID FRACTURED WHEN IT WAS BEING IMPLANTED. ALL THE BROKEN PIECES WERE REMOVED USING GRASPERS. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP IN THE ORIGINAL DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25215317 ↗
• MalfunctionMay 15, 2026Fracture

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, ONE (1) DYNAMITE ULTRABRAID FRACTURED WHEN IT WAS BEING IMPLANTED. ALL THE BROKEN PIECES WERE REMOVED USING GRASPERS. THE PROCEDURE WAS PERFORMED, AFTER A NON SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP IN THE ORIGINAL DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25185165 ↗
• MalfunctionJun 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A RECONSTRUCTION OF LATERAL ANKLE LIGAMENT, THE DYNOMITE 2.0 PK W/NDL 12-0 ULTRABRAID ANCHOR WAS FRACTURED. THE FRACTURED ANCHOR WAS REMOVED WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE USING THE ORIGINALLY DRILLED BONE HOLE AND LEAVING NO VOID IN THE PATIENT, USING AN ANCHOR MATCHING INSTRUMENT TO PREPARE INSERTION SITE. 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 22354415 ↗
• MalfunctionJul 2, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE DYNOMITE PK ANCHOR BROKE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. 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 19657540 ↗
• MalfunctionNov 28, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING SET UP, WHEN OPENING THE BOX, THE DYNOMITE 2.0 PK IMPLANT AND THREAD WERE SEPARATED. THERE WAS A BACK-UP DEVICE AVAILABLE, AND THERE WAS A NON-SIGNIFICANT DELAY REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18217149 ↗
• InjuryApr 18, 2022Separation Failure; Device Dislodged or Dislocated; Separation Failure; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING USE IN UCL REPAIR PROCEDURE, THE DYNOMITE ANCHOR CAME OUT OF THE BONE INSTANTLY, ALSO THE NEEDLES ATTACHED TO THE ANCHORS WERE KIND OF STUCK SO IT WAS A LITTLE STRUGGLE TO GET THE ANCHORS OUT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY AND 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 14138170 ↗
• InjuryApr 18, 2022Separation Failure; Device Dislodged or Dislocated; Separation Failure; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING USE IN UCL REPAIR PROCEDURE, THE DYNOMITE ANCHOR CAME OUT OF THE BONE INSTANTLY, ALSO THE NEEDLES ATTACHED TO THE ANCHORS WERE KIND OF STUCK SO IT WAS A LITTLE STRUGGLE TO GET THE ANCHORS OUT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY AND 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 14138168 ↗
• InjuryDec 27, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING A FOOT & ANKLE SURGERY, THE DYNOMITE 2.0 PK ANCHOR WAS PULLED OUT AFTER THE GUIDE WAS USED WITH A DRILL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087534 ↗
• InjuryNov 16, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING ACL PROCEDURE, INTERNAL TO PATIENT, WHEN THE DYNOMITE 2.0 ULTRABRAID LINE WAS REMOVED, THERE WERE KNOTS AND WEAR ON THE SUTURE, THE WEAR ON THE SUTURE WAS NOTED AFTER IT WAS ALREADY IMPLANTED IN THE PATIENT. THE DEVICE WAS REMOVED FROM THE PATIENT BY TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A S+N BACK-UP DEVICE IN THE SAME BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12822285 ↗
• InjurySep 19, 2021Break; Break

  IT WAS REPORTED THAT DURING A MBO SURGERY, THE THREAD OF THE DYNOMITE BROKE WHILE THE KNOT WAS BEING MADE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12493509 ↗
• MalfunctionAug 17, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING AN ANKLE LIGAMENT REPAIR, THE DYNOMITE ANCHOR CRACKED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12334500 ↗
• InjuryMay 17, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING FOOT AND ANKLE SURGERY, AFTER USING THE DYNOMITE, THE ANCHOR REMAINED ON THE PATIENT'S BODY, BUT THE SUTURE WAS SEPARATED. THE PROCEDURE WAS COMPLETED WITH A DELAY OF MORE THAN 30 MINUTES USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11837254 ↗
• InjuryFeb 3, 2021Break; Break

  IT WAS REPORTED THAT, DURING A LATERAL LIGAMENT RECONSTRUCTION, THE DYNOMITE NEEDLE HAD A BENDING/BREAKING PROBLEM. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR'S DEVICE WITH A DELAY OF LESS THAN OR EQUAL TO 30 MIN. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11275531 ↗
• InjuryFeb 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TEMPOROMANDIBULAR JOINT PROCEDURE, THE MEDICAL STAFF HAVE HAD ISSUES WITH THE "DYNOMITE ANCHOR". THE NEEDLE POPS OFF THE SUTURES AFTER THE ANCHOR IS PLACED AND THEY HAD TO TAKE A NEW NEEDLE AND CRIMP IT ONTO THE SUTURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING THE SAME DEVICE INTO THE SAME BONE HOLE. NO PATIENT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11262784 ↗
• InjuryFeb 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TEMPOROMANDIBULAR JOINT PROCEDURE, THE MEDICAL STAFF HAVE HAD ISSUES WITH THE "DYNOMITE ANCHOR". THE NEEDLE POPS OFF THE SUTURES AFTER THE ANCHOR IS PLACED AND THEY HAD TO TAKE A NEW NEEDLE AND CRIMP IT ONTO THE SUTURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING THE SAME DEVICE INTO THE SAME BONE HOLE. NO PATIENT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11262727 ↗
• MalfunctionJul 15, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING INSERTION, THE ANCHOR BROKE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8789601 ↗
• MalfunctionApr 30, 2019Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ANCHOR WAS BROKEN WHEN THE ANCHOR WAS INSERTED. IT IS UNKNOWN IF A BACK UP DEVICE WAS AVAILABLE OR IF A DELAY WAS CAUSED BY THE DEVICE MALFUNCTION. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8565734 ↗
• MalfunctionJan 11, 2018Break

  IT WAS REPORTED THAT ANCHOR WAS BROKEN. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7183877 ↗
• MalfunctionJan 4, 2018Break

  IT WAS REPORTED THAT THE ANCHOR WAS BROKEN, DURING A MENISCUS REPAIR. NO PATIENT INJURIES WERE REPORTED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7164265 ↗