SPEEDLOCKRecalls & reported problems across all models

We found 4 models of SPEEDLOCK by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Jan 8, 2018 and Dec 3, 2024 — classified as 8 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 SPEEDLOCK problems

SPEEDLOCK models

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

• SPEEDLOCK 23-2001

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  14 reports
• SPEEDLOCK OM-7500

  Fastener, fixation, nondegradable, soft tissue
  8 reports
• SPEEDLOCK 23-2010

  BIT, DRILL
  1 report
• SPEEDLOCK 23-2009

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report

Recent SPEEDLOCK adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• MalfunctionFeb 1, 2022Break; Break

  IT WAS REPORTED THAT, DURING A HIP LABRAL REPAIR SURGERY, THE SPEED LOCK HIP BROKE AT THE STOPPER. IT SNAPPED FROM THE TORQUE OF THE DRILL AND HARD BONE. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING THE SAME DEVICE. SURGEON DRILLED WHAT HE COULD WITH THE DRILL THROUGH THE GUIDE TO START THE HOLE, THEN FREE HANDED THE REST SINCE IT WAS ABLE TO STILL MOUNT ON THE CHUCK. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13415946 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionFeb 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A HIP SCOPE DRILL BROKE AT THE END WHEN IN GUIDE DRILLING, LENGTH OF DELAY UNKNOWN. THERE WAS BACK-UP DEVICE AVAILABLE TO COMPLETE THE PROCEDURE, NO PATIENT INJURIES 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 9706152 ↗

Other Smith & Nephew, Inc. products

• FAST-FIX18 models · 9,554 reports
• JOURNEY566 models · 6,250 reports · 4 recalls
• GENESIS II462 models · 4,599 reports · 2 recalls
• DYONICS, POWERMAX, ELITE2 models · 4,308 reports
• TRIGEN381 models · 3,599 reports · 5 recalls
• LEGION446 models · 2,039 reports · 4 recalls
• REAL INTELLIGENCE32 models · 2,017 reports · 3 recalls
• Coblation62 models · 2,126 reports