MAGNUMRecalls & reported problems across all models

We found 4 models of MAGNUM by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 85 adverse event reports in the FDA's MAUDE database, received between Oct 24, 2017 and Feb 24, 2026 — classified as 14 injuries, 71 malfunctions.

The most frequently reported specific device problem is “Break” (29 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported MAGNUM problems

MAGNUM models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MAGNUM OM-1502

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  69 reports
• MAGNUM OM-9020

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  10 reports
• MAGNUM OM-2500

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  5 reports
• MAGNUM OM-1503

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  1 report

Recent MAGNUM adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryOct 25, 2021Break; Break

  IT WAS REPORTED THAT, DURING SHOULDER ARTHROSCOPY, THE TOP PORTION OF THE "3.2MM MAGNUM PUNCH" BROKE INTO 2 PIECES, INSIDE OF THE PATIENT, WHEN THE SURGEON ATTEMPTED TO PULL IT OUT OF THE BONE. ALL PIECES WERE RECOVERED FROM THE PATIENT USING PLIERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12694465 ↗
• InjurySep 23, 2021Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE AWL OF THE MGNUM PUNCH BROKE. THE AWL IS SHAPED LIKE A "T", AND AT THE JOINT OF THE SHAFT AND THE HANDLE, IT DID NOT LOOK LIKE IT IS WELDED TOGETHER. IT KEPT COMING APART AS THEY TRY TO PULL IT OUT OF THE JOINT/BONE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. NO SURGICAL DELAY WAS REPORTED AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12523400 ↗
• 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 ↗
• MalfunctionMay 19, 2021Break; Break

  IT WAS REPORTED THAT, DURING USE IN AN ARTHROSCOPY, THE T HANDLE OF THE MGNUM PUNCH BROKE AS PULLING IT OUT OF HUMERAL HEAD. A DELAY LESS OR EQUAL THAN 30 MINUTES WERE REPORTED AND THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11851799 ↗
• MalfunctionMay 18, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, THE T HANDLE ON THE MAGNUM PUNCH SNAPPED OFF WHILST PULLING OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITH NO PATIENT INJURY. A DELAY EQUAL TO OR LESS THAN 30 MINUTES WAS REPORTED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11846490 ↗
• 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 ↗
• MalfunctionApr 7, 2021Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR THE MGNUM PUNCH'S HANDLE BROKE FROM THE SHAFT EXTERNALLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11632139 ↗
• 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 ↗

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