SPEEDLOCK 23-2001Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00817470003413), received between Jan 8, 2018 and Dec 3, 2024 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, TWO (2) SPEEDLOCK HIP KNOTLESS WOULD NOT TIGHTEN THE SUTURE. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE USING THE ORIGINAL DRILLED BONE HOLE LEAVING NO VOID IN PATIENT AND USING A SPEEDLOCK HIP DRILL - 3.0 TO PREPARE THE INSERTION SITE WITH NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20839223 ↗
• MalfunctionJun 17, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE ULTRABRAID SUTURE OF THREE SPEEDLOCK KNOTLESS DID NOT PASSED THROUGH THE IMPLANT, THERE WAS A DEFECT WHEN THE SUTURE WAS PASSED INTO THE IMPLANT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY GREATER 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 19549180 ↗
• MalfunctionSep 21, 2021Break; Break

  IT WAS REPORTED THAT DURING ARTHROSCOPY PROCEDURE, THE SUTURE OF THE SPEEDLOCK WAS BROKEN IN THE EYELET OUTSIDE THE PATIENT, SO IT COULD NOT BE PASSED INTO THE ANCHOR. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. THERE WAS NO SURGICAL DELAY NOR PATIENT INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12505377 ↗
• MalfunctionJun 22, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE SPEEDLOCK HIP IMPLANT BROKE. THE INCIDENT OCCURRED BEFORE THE PROCEDURE, NO 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 Patient Involvement

  MAUDE report 10182136 ↗
• MalfunctionMar 17, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, THE RATCHET WHEEL OF THE SPEEDLOCK WAS NOT WORKING AND CAUSED THE SURGEON TO TENSION THE SUTURES BY HAND, WHEN THE KNOB WAS BEING TURNED THE WHOLE DEPLOYMENT KNOB CAME OFF INSIDE THE PATIENT. THE ANCHOR SHAFT AND METAL WIRE WERE REMOVED WITH GRASPERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE IN AN ADDITIONAL BONE HOLE. 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 Known Impact Or Consequence To Patient

  MAUDE report 9840508 ↗
• MalfunctionOct 3, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, WHEN THE DOCTOR WAS GOING TO MALLET IN THE ANCHOR, THE INSERTER AND THE ANCHOR SNAPPED OFF, THE ANCHOR WAS NOT ABLE TO BE USED, THE DEVICE BROKE INTO TWO PIECES AND BROKEN PIECES WERE REMOVED USING AN ARTHROSCOPIC GRASPER. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9150301 ↗
• MalfunctionAug 19, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, ON INSERTION THE DIAL TO TAKE UP AND TENSION THE SUTURE WOULD NOT TURN, THE SUTURE COULD NOT BE TAKEN UP AND THE INTERNAL WIRE COULD BE SEEN AS TWISTED/JAMMED INSIDE. AN ADDITIONAL BONE HOLE WAS DRILLED TO USE THE BACK UP DEVICE. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE, WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8906758 ↗
• MalfunctionAug 19, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, ON INSERTION THE DIAL TO TAKE UP AND TENSION THE SUTURE WOULD NOT TURN, THE SUTURE COULD NOT BE TAKEN UP AND THE INTERNAL WIRE COULD BE SEEN AS TWISTED/JAMMED INSIDE. AN ADDITIONAL BONE HOLE WAS DRILLED TO USE THE BACK UP DEVICE. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE, WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8906732 ↗
• InjuryJul 31, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT ALMOST A YEAR AND A HALF AFTER A RIGHT HIP ARTHROSCOPY LABRAL REPAIR/CAM DEBRIDEMENT THE PATIENT BEGAN EXPERIENCING PAIN. NO INCIDENTS OR TRAUMATIC EPISODES WERE REPORTED IN THIS PERIOD OF TIME. AFTER AN MRI, A HIP ARTHROSCOPY WAS PERFORMED, AT THIS POINT THE LATERAL ANCHOR WAS FOUND DETACHED FROM THE RIM OF THE ACETABULUM AND HANGING BY A THREAD. THE DEVICE WAS RETRIEVED AND LABRAL DEBRIDEMENT WAS PERFORMED.

  Patient problems: Pain

  MAUDE report 8847363 ↗
• InjuryJul 31, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT ALMOST A YEAR AND A HALF AFTER A RIGHT HIP ARTHROSCOPY LABRAL REPAIR/CAM DEBRIDEMENT THE PATIENT BEGAN EXPERIENCING PAIN. NO INCIDENTS OR TRAUMATIC EPISODES WERE REPORTED IN THIS PERIOD OF TIME. AFTER AN MRI A HIP ARTHROSCOPY WAS PERFORMED, AT THIS POINT THE ANTERIOR ANCHOR WAS FOUND TO BE UNSTABLE. THE DEVICE WAS RETRIEVED AND LABRAL DEBRIDEMENT WAS PERFORMED.

  Patient problems: Pain

  MAUDE report 8847350 ↗
• MalfunctionJul 28, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, ON INSERTION THE DIAL TO TAKE UP AND TENSION THE SUTURE WOULD NOT TURN, THE SUTURE COULD NOT BE TAKEN UP AND THE INTERNAL WIRE COULD BE SEEN AS TWISTED/JAMMED INSIDE. AN ADDITIONAL BONE HOLE WAS DRILLED TO USE THE BACK UP DEVICE. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE, WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8834775 ↗
• MalfunctionFeb 22, 2019Break; Noise, Audible

  IT WAS REPORTED THAT DURING A HIP PROCEDURE, THE DEVICE SNARE BROKE UNDER NO TENSION UPON WINDING. THE SURGEON STARTED WINDING AND REDUCING THE SUTURE IN THE DEVICE, AND THEN THE IMPLANT SUTURE MADE A CRACKING SOUND AND BROKE. ADDITIONAL INFORMATION CONFIRM THAT THE ANCHOR DID NOT BROKE AND WAS LEFT INSIDE THE PATIENT. ADDITIONAL BONE HOLES WERE REQUIRED IN ORDER TO COMPLETE THE PROCEDURE WITH ANOTHER BACKUP DEVICE WITH NO SIGNIFICANT DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8362314 ↗
• MalfunctionFeb 22, 2019Break; Noise, Audible

  IT WAS REPORTED THAT DURING A HIP PROCEDURE, THE DEVICE SNARE BROKE UNDER NO TENSION UPON WINDING. THE SURGEON STARTED WINDING AND REDUCING THE SUTURE IN THE DEVICE, AND THEN THE IMPLANT MADE A CRACKING SOUND AND BROKE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURIES. IT IS UNKNOWN IF THERE WAS A DELAY IN THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8362277 ↗
• MalfunctionJan 8, 2018Break

  IT WAS REPORTED THAT THE SUTURE WAS PASSED THROUGH ANCHOR. STARTED WINDING SUTURES UP AND THE INTERNAL WIRE SNAPPED. UNABLE TO LOAD SUTURES ANY FURTHER. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7171130 ↗