SPEEDLOCK OM-7500Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885556724675), received between Dec 30, 2020 and Nov 25, 2022 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SPPEDLOCK ANCHOR BROKE OFF PREMATURELY FROM THE SETTING INSTRUMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15864110 ↗
• InjuryAug 24, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING SURGERY, THE KNOTLESS SPEEDLOCK ANCHORS DID NOT FIXATE PROPERLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

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

  MAUDE report 15287188 ↗
• InjuryAug 24, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING SURGERY, THE KNOTLESS SPEEDLOCK ANCHORS DID NOT FIXATE PROPERLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Rupture

  MAUDE report 15287167 ↗
• InjuryNov 17, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, WHEN PULLING THE THREADS INTO THE ANCHOR, A GUIDE RAIL DID NOT TRANSPORT THE THREAD FURTHER. THIS CAUSED THE THREAD TO BE PULLED OUT OF THE SEAM. THE SPEEDLOCK WAS SIMPLY REMOVED WITH THE INSERTER. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THE BACK-UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE NO DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12833268 ↗
• InjuryNov 16, 2021Material Twisted/Bent; Firing Problem; Material Twisted/Bent; Firing Problem

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE, THERE WAS A FAILURE OF THE SPEEDLOCK IMPLANT. THE SUTURES WERE NOT PULLED INTO THE SHAFT OF THE INSERTER INTO THE IMPLANT. THERE WAS EXCESSIVE SUTURE INTO THE JOINT AND THERE WAS NO SALVAGE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12821361 ↗
• MalfunctionJul 22, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, WHEN SURGEON IMPLANTED THE SPEEDLOCK ANCHOR AND TWISTED TO TENSION THE SUTURES WERE NOT TIGHTENED. THE DEVICE JUST KEPT TURNING WITHOUT FEEDING THROUGH THE SUTURES. PROCEDURE FINISHED WITH S&N BACKUP DEVICE. SURGICAL DELAY OF LESS THAN OR 30 MINUTES. NO FURTHER COMPLICATIONS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12213955 ↗
• InjuryDec 30, 2020Break; Break

  IT WAS REPORTED THAT DURING A SURGERY THE SPEEDLOCK ANCHOR CRACKED WHILE INSERTING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT 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 11095582 ↗
• InjuryDec 30, 2020Break; Break

  IT WAS REPORTED THAT DURING A SURGERY THE SPEEDLOCK ANCHOR CRACKED WHILE INSERTING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT 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 11095565 ↗