SPEEDSCREWRecalls & reported problems across all models

We found 3 models of SPEEDSCREW by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 102 adverse event reports in the FDA's MAUDE database, received between Oct 24, 2017 and Jan 9, 2026 — classified as 36 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Break” (37 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 SPEEDSCREW problems

SPEEDSCREW models

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

• SPEEDSCREW OM-6500

  Screw, fixation, bone
  99 reports
• SPEEDSCREW OM-8500

  Screw, fixation, bone
  2 reports
• SPEEDSCREW OM-9820

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report

Recent SPEEDSCREW adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Failure to Advance

  IT WAS REPORTED THAT, DURING AN ACL AVULSION, AN OPUS SPEEDSCREW IMPLANT DIDN¿T PROVIDE FINAL TENSIONING. WHEN IT WAS MOVED TO ACCURATE INDIVIDUAL TENSIONING, IT STOPPED WORKING. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A COMPETITOR DEVICE, A SWIVEL LOCK. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24022468 ↗
• MalfunctionNov 30, 2025Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE SUTURE OF TWO (2) OPUS SPEEDSCREW IMPLANTS BROKE THERE WAS A LOCKING DEFECT OF ONE OF THE TWO WIRES IN THE ANCHORS. THE PROCEDURE WAS RESUMED, WITH AN EQUIVALENT SN BACK-UP. NO ADDITIONAL HOLE WAS DRILLED. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23677085 ↗
• MalfunctionNov 26, 2025Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE OPUS SPEEDSCREW ANCHOR SUTURE BROKE. THE PROCEDURE WAS RESUMED, WITH AN EQUIVALENT SN BACK-UP. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659297 ↗
• MalfunctionOct 9, 2025Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT DURING AN MPFL RECONSTRUCTION ON THE MEDIAL FEMORAL CONDYLE, A SPEEDSCREW WAS USED TO TENSION ULTRATAPES FROM A HEALICOIL IN THE PATELLA. STANDARD BONE PREPARATION WAS PERFORMED (2.4 PASSING PIN, 4.5 CANNULATED DRILL, AND SPEEDSCREW TAP). WHILE FEEDING THE TAPES INTO THE ANCHOR BY ROTATING THE KNOB, SOMETHING SNAPPED WITHIN THE OPUS IMPLANT INSERTER, DISABLING THE ABILITY TO TENSION THE TAPES. THE OPUS IMPLANT ANCHOR WAS REMOVED AND REPLACED WITH A BACKUP DEVICE IN A NEW PILOT HOLE. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED, PATIENT IS FINE.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 23262929 ↗
• MalfunctionJun 12, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE OPUS SPEEDSCREW IMPLANT WAS NOT WORKING PROPERLY AND BROKE INSIDE THE PATIENT; SURGERY WAS COMPLETED USING A BACK-UP DEVICE INSTEAD WITH NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22199743 ↗
• MalfunctionNov 13, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SPEEDSCREW BROKE DUE TO HARD BONE. ALL THE PIECES WERE REMOVED WITH ARTHROSCOPIC GRASPERS. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THE BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE. THE INSTRUMENT TO PREPARE THE INSERTION SITE WAS A 3.8 AWL THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675579 ↗
• MalfunctionSep 5, 2024Unstable; Unstable

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, WHILE TENSIONING THE SPEEDSCREW SUTURES, THERE WAS A CRACK FROM THE ANCHOR AND THE SUTURES BECAME LOOSE AND WERE NOT ABLE TO BE TENSIONED AGAIN. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD IN A NEW HOLE, THEREFORE THERE WAS A VOID LEFT IN THE PATIENT. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 20153184 ↗
• MalfunctionSep 5, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A CUFF REPAIR, TWO (2) OPUS SPEED CREW ANCHORS DID NOT DEPLOY ALL THE WAY AND BROKE THE SUTURES ATTACHED TO THE TENDON. THE ENTIRE CONSTRUCT AND THE FAILED ANCHOR HAD TO BE REMOVED FROM THE PATIENT. A THIRD (3RD) OPUS SPEED CREW ANCHOR ALSO FAILED TO FULLY DEPLOY BUT DID NOT PULL THE SUTURE OUT OF THE TENDON. THE ANCHOR WAS LEFT IN THE PATIENT AND WAS SECURE. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20153016 ↗
• MalfunctionAug 27, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A CUFF REPAIR, TWO (2) OPUS SPEED CREW ANCHORS DID NOT DEPLOY ALL THE WAY AND BROKE THE SUTURES ATTACHED TO THE TENDON. THE ENTIRE CONSTRUCT AND THE FAILED ANCHOR HAD TO BE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 20082438 ↗
• MalfunctionFeb 16, 2024Break; Failure to Advance; Material Deformation; Break; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SUTURES OF THE OPUS SPEEDSCREW DID NOT WENT DOWN WHEN THEY WERE PULLED. THE SUTURES WERE CUT AND ANCHOR WAS REMOVED WITH THE SCREWDRIVER. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18720688 ↗
• MalfunctionFeb 12, 2024Break; Break

  IT WAS REPORTED THAT TWO OPUS SPEEDSCREW´S GREEN SUTURES SNAPPED WHEN PASSING INTO THE ANCHOR. THE ANCHOR WAS REMOVED FROM THE PATIENT USING TWEEZERS. THE PATIENT REQUIRED ADDITIONAL ANESTHESIA FOR THE REMOVAL OF THE ANCHOR. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THERE WAS A DELAY GREATER THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691629 ↗
• MalfunctionFeb 2, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE OPUS SPEEDSCREW ANCHOR WAS SLIGHTLY DEFORM AND THE BRIDGE INSIDE THE EYELET WAS TORN ON ONE SIDE. THE DEFICIENCY WAS OBSERVED WHILE PERFORMING THE INVESTIGATION FOR THE DEVICE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18630352 ↗
• MalfunctionJan 31, 2024Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, THE SPEEDSCREW IMPLANT'S SNARE GOT STUCK IN THE ANCHOR, WHEN TENSIONING THE SUTURES, AND PULLED OFF THE INTERNAL SUTURE, THEREFORE IT WAS NOT ABLE TO GAIN ADEQUATE TENSION ON THE SUTURES IN THE CUFF. THE ANCHOR WAS REMOVED WITH DIFFICULTY, AND IT BROKE BEFORE IT WAS COMPLETELY REMOVED. A BONE NIBBLER WAS USED TO REMOVE THE BROKEN PART OF THE ANCHOR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18619968 ↗
• MalfunctionJan 3, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION, BEFORE AN ARTHROSCOPY PROCEDURE, THE OPUS SPEEDSCREW IMPLANT WAS MAKING AN INTERNAL RATTLING SOUND LIKE IT IS BROKEN ON THE INSIDE. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED. AS PER INVESTIGATION RESULTS THE INSERTION TOOL TIP AND THE IMPLANT WERE FOUND TO BE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18435785 ↗
• MalfunctionDec 29, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, TWO (2) SPEED SCREW IMPLANTS COULD NOT BE TENSIONED AFTER BOTH ANCHORS WERE PLACED. BOTH IMPLANTS WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE USING THE ORIGINAL DRILLED BONE HOLE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418922 ↗

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