MAGNUM OM-1502Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 00817470005486), received between Oct 24, 2017 and Feb 24, 2026 — classified as 10 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Failure to Cycle

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, A MAGNUM KNOTLESS WAS IMPLANTED, BUT WHEN ROTATING THE SUTURE RATCHET KNOBS, THE SUTURE DID NOT TIGHTEN. THE ANCHOR WAS NOT RETRIEVED, NO VOID WAS LEFT BUT THE TENDON WAS NOT ABLE TO BE SECURED TO THE ANCHOR AND BONE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING AN EQUIVALENT S+N BACK-UP IN AN ADDITIONALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24431142 ↗
• MalfunctionSep 22, 2025Failure to Fire; Material Deformation; Failure to Fire; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE, ONE (1) MAGNUM 2 KNOTLESS IMPLANT WAS TRIGGERED THREE TIMES, BUT THE INSERTER DID NOT RELEASE FROM THE ANCHOR. THE SURGEON MANAGED TO EVENTUALLY DETACH THE INSERTER FROM THE ANCHOR BY TAPPING THE INSERTER UPWARDS WITH A MALLET, AND HAD TO TIE A KNOT TO COMPLETE THE REPAIR WITH THE ANCHOR. THE IMPLANT WAS LEFT SECURED IN POSITION, BUT IT DID NOT LOCK THE SUTURE IN PLACE AS A KNOTLESS ANCHOR SHOULD. THE TIP OF THE INSERTER SHOWED SIGN OF DAMAGE, IT LOOKED LIKE IT HAD EXTRA MATERIAL LEFT IN IT THAT POSSIBLY SHOULD HAVE DEPLOYED WITH THE ANCHOR OR RETRACTED INTO THE INSERTER. THERE WAS A 10-MINUTE SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23110470 ↗
• MalfunctionNov 21, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, TWO (2) MAGNUM 2 KNOTLESS SUTURE SNAPPED WHEN WINDING THE KNOB AFTER SECURING THE ANCHOR ON THE PATIENT'S BONE. 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 18187781 ↗
• InjurySep 27, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE, THE MAGNUM KNOTLESS FIXATION IMPLANT FAILED TO TENSION THE SUTURES AS THOUGH THE INTERNAL WIRES WERE BROKEN. THE PROCEDURE WAS COMPLETED WITH A 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 15491875 ↗
• InjuryAug 9, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE "MAGNUM 2 KNOTLESS IMPLANT" BROKE IN SEVERAL PIECES DURING THE IMPLANTATION. ALTHOUGH A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE, IT IS UNKNOWN IF THERE WAS A SURGERY DELAY. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12298187 ↗
• InjuryApr 8, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING PROCEDURES ONE DOCTOR HAS BEEN HAVING AN ISSUE WITH THE MAGNUM 2.8 ANCHORS. HE HAS HAD A STRING OF IMPLANTS THAT HAVEN'T BEEN RELEASING WELL AFTER IMPLANTATION. IN SOME CASES, HE HAS NEEDED TO REALLY PULL ON THE INSERTER TO GET TO DETACH OR EVEN USE A MALLET TO BACK IT OUT. THE EXACT AMOUNT OF TIMES THIS HAS HAPPENED, NUMBER OF DEVICES, PATIENTS AND PROCEDURES INVOLVED IS UNKNOWN. UNKNOWN IF THERE WAS ANY DELAY OR BACKUP AVAILABLE. NO PATIENT INJURIES 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11633510 ↗
• InjuryApr 8, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING PROCEDURES ONE DOCTOR HAS BEEN HAVING AN ISSUE WITH THE MAGNUM 2.8 ANCHORS. HE HAS HAD A STRING OF IMPLANTS THAT HAVEN'T BEEN RELEASING WELL AFTER IMPLANTATION. IN SOME CASES, HE HAS NEEDED TO REALLY PULL ON THE INSERTER TO GET TO DETACH OR EVEN USE A MALLET TO BACK IT OUT. THE EXACT AMOUNT OF TIMES THIS HAS HAPPENED, NUMBER OF DEVICES, PATIENTS AND PROCEDURES INVOLVED IS UNKNOWN. UNKNOWN IF THERE WAS ANY DELAY OR BACKUP AVAILABLE. NO PATIENT INJURIES 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11633497 ↗
• MalfunctionMar 18, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE MAGNUM SUTURE LOST ITS TENSION, IT APPEARED TO SLIP AFTER THE POINT WHERE THE ANCHOR LOCKED DOWN ON THE SUTURE INTERNALLY. THE INSTRUMENT USED TO PREPARE THE INSERTION SITE WAS A MAGNUM PUNCH 3.2 MM. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY OF LESS THAN OR EQUAL TO 30 MIN. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11513100 ↗
• MalfunctionFeb 25, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE MAGNUM KNOTLESS IMPLANT SUTURE SLIPPED OUT WITH THE ANCHOR AND THE TENSION WAS LOST ON THE CUFF. AN ADDITIONAL BONE HOLE WAS MADE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE. A VOID WAS LEFT IN THE JOINT BUT 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: Unspecified Tissue Injury

  MAUDE report 11378565 ↗
• InjuryFeb 25, 2021Break; Break

  IT WAS REPORTED THAT TWO MAGNUM 2 KNOTLESS IMPLANTS WERE USED IN A ROTATOR CUFF REPAIR WITHOUT ISSUES. HOWEVER, AFTER THE SURGERY, AN X-RAY WAS PERFORMED AND A PIECE OF METAL SEEMED TO BE IN THE JOINT SPACE. THERE WAS NO DELAY AND THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO COMPLICATIONS 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 11378427 ↗
• InjuryFeb 25, 2021Break; Break

  IT WAS REPORTED THAT TWO MAGNUM 2 KNOTLESS IMPLANTS WERE USED IN A ROTATOR CUFF REPAIR WITHOUT ISSUES. HOWEVER, AFTER THE SURGERY, AN X-RAY WAS PERFORMED AND A PIECE OF METAL SEEMED TO BE IN THE JOINT SPACE. THERE WAS NO DELAY AND THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO COMPLICATIONS 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 11378373 ↗
• MalfunctionJan 13, 2021Failure to Cycle; Failure to Cycle

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE MAGNUM 2 KNOTLESS IMPLANT DID NOT LOCK DOWN ON THE SUTURES EFFECTIVELY SO THEY LOST THEIR TENSION ON THE CUFF. THE SURGEON TIED DOWN MANUALLY AND THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE WITH A DELAY OF LESS THAN OR EQUAL TO 30 MIN. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11164780 ↗
• InjuryJan 13, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE MAGNUM 2 KNOTLESS IMPLANT ANCHOR'S SUTURES LOOSENED AND THE SURGEON LOST TENSION ON THE CUFF. THEY HAD TO BE MANUALLY TIE DOWN THE CUFF. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE, WHICH WAS USED IN A ADDITIONALLY DRILLED BONE HOLE. A DELAY OF LESS THAN OR EQUAL TO 30 MIN. NO FURTHER 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; Perforation

  MAUDE report 11158799 ↗
• MalfunctionJan 13, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE MAGNUM 2 KNOTLESS IMPLANT ANCHOR'S SUTURES LOOSENED AND THE SURGEON LOST TENSION ON THE CUFF. THEY HAD TO BE MANUALLY TIE DOWN THE CUFF. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE, WHICH WAS USED IN A ADDITIONALLY DRILLED BONE HOLE. A DELAY OF LESS THAN OR EQUAL TO 30 MIN. NO FURTHER 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 11158763 ↗
• MalfunctionJan 13, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE MAGNUM 2 KNOTLESS IMPLANT ANCHOR'S SUTURES LOOSENED AND THE SURGEON LOST TENSION ON THE CUFF. THEY HAD TO BE MANUALLY TIE DOWN THE CUFF. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE, WHICH WAS USED IN A ADDITIONALLY DRILLED BONE HOLE. A DELAY OF LESS THAN OR EQUAL TO 30 MIN. NO FURTHER 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 11158720 ↗
• MalfunctionDec 30, 2020Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, WHEN THE MAGNUM 2 ANCHORS WERE BEING INSERTED, THE RATCHET MECHANISM APPEARED TO FAILED AND IT WAS NOT POSSIBLE TO TENSION THE SUTURES. THE ANCHORS WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE IN THE SAME BONE HOLE. NO OTHER COMPLY AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD CATIONS WERE REPORTED. ALL BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11098580 ↗
• MalfunctionDec 30, 2020Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, WHEN THE MAGNUM 2 ANCHORS WERE BEING INSERTED, THE RATCHET MECHANISM APPEARED TO FAILED AND IT WAS NOT POSSIBLE TO TENSION THE SUTURES. THE ANCHORS WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE IN THE SAME 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11098556 ↗
• MalfunctionDec 30, 2020Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, WHEN THE MAGNUM 2 ANCHORS WERE BEING INSERTED, THE RATCHET MECHANISM APPEARED TO FAILED AND IT WAS NOT POSSIBLE TO TENSION THE SUTURES. THE ANCHORS WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE IN THE SAME 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11098524 ↗
• InjuryDec 23, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, 2 MAGNUM DEVICES AND 1 SPEEDSCREW WAS USED FOR THE LATERAL ROW. THE FIRST MAGNUM WAS FOUND TO BE SURFACED FROM THE IMPLANT SITE AFTER THE DEPLOYMENT, A SECOND MAGNUM WAS USED AT THE SAME PUNCH HOLE. THE SURGEON PERFORMED AN EXTERNAL MANUAL MANIPULATION OF THE SHOULDER, THEN HE USED THE 5.5MM SPEEDSCREW FOR THE LATERAL ROW AT THIS TIME IT WAS NOTICE THAT THE SECOND MAGNUM DEVICE WAS FOUND PULLED OUT AGAIN FROM THE MEDIA ROW IMPLANT SITE. THE DEVICE WAS REMOVED, AN ADDITIONAL BONE HOLE WAS REQUIRED IN ORDER TO COMPLETE THE SURGERY USING A NEW MAGNUM WIRE. NO SIGNIFICANT DELAY OR OTHER COMPLICATIONS 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 11068753 ↗
• MalfunctionOct 23, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN OPEN ROTATOR CUFF REPAIR PROCEDURE, AFTER LOADING THE MAGNUM IMPLANT INTO THE DEVICE, THE SURGEON REMOVED THE SUTURE SLACK OUTSIDE OF THE JOINT USING THE RATCHET, PUSHED THE DEVICE INTO THE PILOT HOLE, THEN REMOVED FURTHER SLACK WHILST THE ANCHOR WAS INSERTED INTO THE PILOT HOLE. AT THIS POINT, THE WIRE MECHANISM SNAPPED AND THE RATCHET SYSTEM OF THE MAGNUM WOULD NOT WORK. THE SNARE WIRE THEN POKED OUT OF THE DEVICE NEAR THE RATCHET KNOB. THE SURGEON REMOVED THE DEVICE AND FREED BOTH SUTURE ENDS FROM THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A SUTURE FROM A METAL TWINFIX ULTRA ANCHOR WHICH WAS INSERTED INTO THE PATIENT AS THE MEDIAL ROW ANCHOR AND THE SUTURE LIMBS OF WHICH WERE THEN LOADED INTO THE MAGNUM 2 ANCHOR IN THE SAME 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

  MAUDE report 10727397 ↗
• MalfunctionOct 23, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN OPEN ROTATOR CUFF REPAIR PROCEDURE, AFTER LOADING THE MAGNUM IMPLANT INTO THE DEVICE, THE SURGEON REMOVED THE SUTURE SLACK OUTSIDE OF THE JOINT USING THE RATCHET, PUSHED THE DEVICE INTO THE PILOT HOLE, THEN REMOVED FURTHER SLACK WHILST THE ANCHOR WAS INSERTED INTO THE PILOT HOLE. AT THIS POINT, THE WIRE MECHANISM SNAPPED AND THE RATCHET SYSTEM OF THE MAGNUM WOULD NOT WORK. THE SNARE WIRE THEN POKED OUT OF THE DEVICE NEAR THE RATCHET KNOB. THE SURGEON REMOVED THE DEVICE AND FREED BOTH SUTURE ENDS FROM THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A SUTURE FROM A METAL TWINFIX ULTRA ANCHOR WHICH WAS INSERTED INTO THE PATIENT AS THE MEDIAL ROW ANCHOR AND THE SUTURE LIMBS OF WHICH WERE THEN LOADED INTO THE MAGNUM 2 ANCHOR IN THE SAME 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

  MAUDE report 10727357 ↗
• InjuryAug 6, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE SURGERY, THE SUTURE LOST ITS TENSION ON THE CUFF AFTER THE POINT LOCKING DOWN WITH THE ANCHOR. AS PER COMPLAINANT REPORT, IT WAS LIKE THE INTERNAL LOCKING SYSTEM ON THE ANCHOR WHICH CAUSED THAT THE ANCHOR DID NOT LOCK DOWN SUFFICIENTLY. SURGERY WAS COMPLETED USING A SMITH AND NEPHEW BACK-UP DEVICE WITH NO SIGNIFICANT DELAY 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 10371503 ↗
• MalfunctionAug 6, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE SURGERY, THE SUTURE LOST ITS TENSION ON THE CUFF AFTER THE POINT LOCKING DOWN WITH THE ANCHOR. AS PER COMPLAINANT REPORT, IT WAS LIKE THE INTERNAL LOCKING SYSTEM ON THE ANCHOR WHICH CAUSED THAT THE ANCHOR DID NOT LOCK DOWN SUFFICIENTLY. SURGERY WAS COMPLETED USING A SMITH AND NEPHEW BACK-UP DEVICE WITH NO SIGNIFICANT DELAY REPORTED.

  Patient problems: No Information

  MAUDE report 10371491 ↗
• MalfunctionJul 29, 2020Firing Problem; Firing Problem

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY SURGERY, WHEN THE IMPLANT WAS TRIED TO BE FIRED NOTHING HAPPENED. THE DEVICE WAS VISUALLY INSPECTED BY THE SURGEON BUT THERE WAS NO APPARENT REASON FOR THE FAILURE REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. NO PATIENT INJURIES OR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10339587 ↗
• InjuryMay 7, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE THE MAGNUM 2 ANCHOR WOULD NOT LOAD SUTURES, THE ANCHOR COULD NOT BE USED AND IT WAS NOT IMPLANTED IN THE PATIENT. A COMPETITIVE ANCHOR WAS USED INSTEAD. NO SIGNIFICANT DELAY 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 10034191 ↗