SPEEDSCREW OM-6500Recalls & reported problems

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 00817470005196), received between Oct 24, 2017 and Jan 9, 2026 — classified as 34 injuries, 65 malfunctions.

The most frequently reported specific device problem is “Break” (34 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 99 reports, 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 ↗
• MalfunctionOct 20, 2023Break; Break

  IT WAS REPORTED THAT THE SPEEDSCREW HAD A BROKEN IMPLANT. 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 17971671 ↗
• InjuryAug 21, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, WHILE THE SURGEON WAS ENGAGING THE SUTURES THROUGH THE SPEEDSCREW KNOTLESS ANCHOR, THE SUTURES STOPPED MOVING AS THE SURGEON WAS TWISTING THE BACK OF THE ANCHOR. AS IT BECAME EVIDENT THE SUTURES WERE NOT ADVANCING THE SURGEON SET THE INTERNAL LOCKING MECHANISM AND DETACHED THE ANCHOR FROM THE INSERTER, AND THEN USE THE REMOVAL OWL TO BACK THE ANCHOR OUT OF THE BONE. THE ANCHOR PUSHED INTO THE HUMERAL HEAD AS THE BONE QUALITY WAS RELATIVELY POOR. THE SUTURES WERE CUT FLUSH WITH THE BONE AND INSERTED INTO A NEW SPEEDSCREW KNOTLESS ANCHOR TO COMPLETE THE PROCEDURE, DRILLING AN ADDITIONAL BONE HOLE PREPARED WITH A SPEEDSCREW TAP. THE ORIGINAL ANCHOR WAS LEFT BURIED DEEP IN THE BONE. 5 MINUTES DELAY WAS REPORTED, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 17585280 ↗
• InjuryMay 24, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A BICEP TENDON SURGERY WHEN THE OPUS SPEEDSCREW IMPLANT WAS INSERTED INTO THE PREPARED HOLE, THE FIRST BOTH ENDS OF THE SUTURE WERE TRANSPORTED CORRECTLY BY TURNING THE HANDLE, BUT SUDDENLY ONE OF THE TWO ENDS OF THE SUTURE STOPPED. IT WAS NOT POSSIBLE TO GIVE TENSION ONTO THE SECOND END OF THE SUTURE. THE OTHER END COULD BE TENSIONED BY TURNING THE HANDLE. THE ANCHOR WAS COMPLETELY REMOVED USING AN EXTRACTION DEVICE (OM-9630). THE PROCEDURE WAS COMPLETED BY CHANGING THE SURGICAL TECHNIQUE INTO A TENOTOMY WITH A NON-SIGNIFICANT SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16994140 ↗
• InjuryMar 1, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN SCREWING THE SPEEDSCREW, THE SLUGGISHNESS WAS ALREADY NOTICEABLE, THREADS COULD NOT BE PULLED IN, THE ANCHOR WAS BROKEN OFF. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A NON-SIGNIFICANT SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16461307 ↗
• InjurySep 29, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT DURING A SUBACROMIAL DECOMPRESSION WITH A ROTATOR CUFF REPAIR TWO HEALICOIL ANCHORS WERE DEPLOYED FOR THE MEDIAL ROW OF A DOUBLE ROW REPAIR. THEN FOR THE LATERAL ROW, TWO (2) SPEEDSCREWS WERE USED. DURING TENSIONING OF THE SPEEDSCREWS, THE SUTURE WITHIN ONE OF THE SPEEDSCREWS GOT STUCK WHICH PREVENTED THE FUNCTION SWITCH FROM MOVING INTO THE POSITION FOR SUTURE LOCKING. IN ATTEMPTS TO TROUBLESHOOT THE ISSUE, THE FUNCTION SWITCH BROKE OFF, AND THE SUTURE BROKE WITHIN THE SPEEDSCREW. THIS SPEEDSCREW ANCHOR WAS REMOVED FROM THE BONE, AND A NEW SPEEDSCREW ANCHOR WAS DEPLOYED INTO THE SAME PREPARED HOLE. THE HEALICOIL ANCHORS WERE NOT REPLACED AS THE DOCTOR WAS SATISFIED WITH A SINGLE SUTURE COMING FROM THE RESPECTIVE HEALICOIL. NO BONE AUGMENT WAS REQUIRED TO FILL ANY HOLES. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE WERE NO NEGATIVE IMPACTS ON THE PATIENT'S HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15508532 ↗
• MalfunctionMay 13, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A PROCEDURE, THE PULL-IN THREAD OF TWO SPEEDSCREW IMPLANTS BROKE PREMATURELY. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14396168 ↗
• InjuryApr 12, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE TIP OF THE OPUS SPEEDSCREW IMPLANT BROKE DURING IMPACT. ALL PARTS OF THE BROKEN SCREW WERE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14089737 ↗
• InjuryApr 4, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE SPEEDSCREW ANCHOR WOULD NOT RELEASE FROM INSERTER AFTER TENSION LOCK HAD BEEN ACTIVATED. THE ANCHOR AND INSERTER HAD TO BE EXPLANTED AND A NEW BONE HOLE WITH NEW SPEEDSCREW ANCHOR WERE USED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A NON-SIGNIFICANT DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Rupture

  MAUDE report 14004978 ↗
• InjuryMar 29, 2022Break; Break

  IT WAS REPORTED THAT, DURING A BICEPS TENODESIS, THE BICEPSTENDON WAS ARMED WITH AN ULTRABRAID 2 SUTURE. WHEN THE BUTTON FOR TIGHTENING THE SUTURES TURNED, THE SETTING DEVICE OF THE OPUS ANCHOR COULD NOT BE REMOVED AND THE TENDON WAS NOT ATTACHED. SUBSEQUENTLY, THE TENDON WAS FREED AGAIN AND THE ANCHOR WAS REMOVED FROM THE BONE. THIS SHOWED THAT THE EYELET WAS BROKEN. THE ANCHOR WAS COMPLETE REMOVED BY TURNING THE INSERTER OUT OF THE BONE. A VOID WAS FROM THE ORIGINAL HOLE WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED CHANGING THE SURGICAL TECHNIQUE ONLY A SUBACROMIAL DECOMPRESSION, WITH NO FIXATION OF THE BICEPS TENDON. NON-SIGNIFICANT DELAY WAS REPORTED, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Rupture

  MAUDE report 13935719 ↗
• InjuryFeb 18, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, A LITTLE PIECE OF METAL OF THE OPUS SPEEDSCREW ANCHOR BROKE, AND IT WAS LEFT INSIDE OF THE PATIENT BECAUSE THE REMOVAL PROCESS WOULD HAVE DONE MORE DAMAGE THAN GOOD. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13559488 ↗