Arthrex® AR-4502Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00888867102675), received between Jul 21, 2016 and Dec 18, 2018 — classified as 66 injuries.

The most frequently reported specific device problem is “Positioning Failure” (32 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 66 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2018Mechanical Jam

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR PROCEDURE, THE SURGEON WAS ATTEMPTING TO USE A SPEED CINCH, AR-4502, LOT: F184675. BEFORE IMPLANTING THE FIRST IMPLANT, THE TOGGLE BUTTON JAMMED AND THE SURGEON COULDN'T GET THE TRIGGER INTO THE #1 POSITION. A SECOND SPEED CINCH, AR-4502, FROM LOT: 10056166 WAS OPENED AND THE SURGEON WAS ABLE TO IMPLANT THE FIRST IMPLANT WITH NO ISSUES. WHEN HE WENT TO INSERT THE SECOND IMPLANT, THE SECOND IMPLANT WOULD NOT DEPLOY. THE FIRST IMPLANT WAS CUT OUT AND A THIRD SPEED CINCH, AR-4502, LOT: 10056166, WAS OPENED AND THE SAME EVENT OCCURRED. THE FIRST IMPLANT WAS SEATED NICELY BUT THE SECOND IMPLANT WOULD NOT DEPLOY. THE FIRST IMPLANT WAS CUT OUT AND THE SURGEON DECIDED TO PERFORM A MENISECTOMY INSTEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8174841 ↗
• InjuryDec 18, 2018Mechanical Jam

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR PROCEDURE, THE SURGEON WAS ATTEMPTING TO USE A SPEED CINCH, AR-4502, LOT: F184675. BEFORE IMPLANTING THE FIRST IMPLANT, THE TOGGLE BUTTON JAMMED AND THE SURGEON COULDN'T GET THE TRIGGER INTO THE #1 POSITION. A SECOND SPEED CINCH, AR-4502, FROM LOT: 10056166 WAS OPENED AND THE SURGEON WAS ABLE TO IMPLANT THE FIRST IMPLANT WITH NO ISSUES. WHEN HE WENT TO INSERT THE SECOND IMPLANT, THE SECOND IMPLANT WOULD NOT DEPLOY. THE FIRST IMPLANT WAS CUT OUT AND A THIRD SPEED CINCH, AR-4502, LOT: 10056166, WAS OPENED AND THE SAME EVENT OCCURRED. THE FIRST IMPLANT WAS SEATED NICELY BUT THE SECOND IMPLANT WOULD NOT DEPLOY. THE FIRST IMPLANT WAS CUT OUT AND THE SURGEON DECIDED TO PERFORM A MENISECTOMY INSTEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8174820 ↗
• InjuryDec 13, 2018Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR PROCEDURE, THE SUTURE ON BOTH SPEED CINCHES, LOT: 10145050 AND 10175535, BROKE BEFORE TYING THE KNOTS. BOTH SPEED CINCHES WERE USED CORRECTLY AS PER DFU. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION PROVIDED 11/27/2018: THREE OF THE FOUR IMPLANTS WERE LEFT IN THE MENISCUS. THE FOURTH IMPLANT DID NOT DEPLOY PROPERLY AND WAS EASILY RETRIEVED. THE CASE WAS COMPLETED WITH A MENISCAL CINCH INSTEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8160230 ↗
• InjuryDec 13, 2018Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR PROCEDURE, THE SUTURE ON BOTH SPEED CINCHES, LOT: 10145050 AND 10175535, BROKE BEFORE TYING THE KNOTS. BOTH SPEED CINCHES WERE USED CORRECTLY AS PER DFU. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION PROVIDED (B)(6) 2018: THREE OF THE FOUR IMPLANTS WERE LEFT IN THE MENISCUS. THE FOURTH IMPLANT DID NOT DEPLOY PROPERLY AND WAS EASILY RETRIEVED. THE CASE WAS COMPLETED WITH A MENISCAL CINCH INSTEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8160206 ↗
• InjuryNov 27, 2018Retraction Problem; Material Twisted/Bent

  IT WAS REPORTED THAT UPON DEPLOYING THE FIRST ANCHOR, THE DEPLOYMENT ROD ON THE AR-4502, SPEED CINCH CURVED NEEDLE WITH TWO PEEK IMPLANTS AND 2.0 FIBERWIRE WAS BENT AND UNABLE TO RETRACT TO ALLOW THE SECOND ANCHOR TO DEPLOY. THEN AFTER MOVING THE NUMBER TWO POSITION THE TRIGGER WAS FIRMLY LOCKED AND WOULD NOT ALLOW PASSAGE OF THE SECOND ANCHOR. THIS OCCURRED DURING A MENISCAL REPAIR PROCEDURE. THE REP STATED THAT THE SURGEON ELECTED TO USE THE MENISCAL CINCHES TO COMPLETE THE REPAIR. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 11/08/2018: THE REP CONFIRMED THAT A TOTAL OF THREE AR-4502 FAILED DURING THE MENISCAL REPAIR PROCEDURE (LOT: 10056961 / QTY. 1 AND LOT: 10135406 / QTY. 2). THE REP STATED THAT AR-4502 (LOT: 10056961) AND AR-4502 (LOT: 10135406 X 1) FAILED WHILE DEPLOYING THE FIRST ANCHOR DUE TO A BENT DEPLOYMENT ROD, AND WOULD NOT RETRACT TO ALLOW THE SECOND ANCHOR TO DEPLOY. THE REP CONFIRMED THAT THE FIRST ANCHOR FROM BOTH AR-4502 (LOT: 10056961 & LOT: 10135406 X1) DEPLOYED SUCCESSFULLY, AND WERE NOT RETRIEVED. THE THIRD AR-4502 (LOT: 10135406) HAD A TRIGGER THAT WAS FIRMLY LOCKED AND WOULD NOT ALLOW PASSAGE OF THE SECOND ANCHOR. THE REP C

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8107651 ↗
• InjuryNov 27, 2018Retraction Problem; Material Twisted/Bent; Positioning Problem

  IT WAS REPORTED THAT UPON DEPLOYING THE FIRST ANCHOR, THE DEPLOYMENT ROD ON THE AR-4502, SPEED CINCH CURVED NEEDLE WITH TWO PEEK IMPLANTS AND 2.0 FIBERWIRE WAS BENT AND UNABLE TO RETRACT TO ALLOW THE SECOND ANCHOR TO DEPLOY. THEN AFTER MOVING THE NUMBER TWO POSITION THE TRIGGER WAS FIRMLY LOCKED AND WOULD NOT ALLOW PASSAGE OF THE SECOND ANCHOR. THIS OCCURRED DURING A MENISCAL REPAIR PROCEDURE. THE REP STATED THAT THE SURGEON ELECTED TO USE THE MENISCAL CINCHES TO COMPLETE THE REPAIR. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 11/08/2018: THE REP CONFIRMED THAT A TOTAL OF THREE AR-4502 FAILED DURING THE MENISCAL REPAIR PROCEDURE (LOT: 10056961 / QTY. 1 AND LOT: 10135406 / QTY. 2). THE REP STATED THAT AR-4502 (LOT: 10056961) AND AR-4502 (LOT: 10135406 X 1) FAILED WHILE DEPLOYING THE FIRST ANCHOR DUE TO A BENT DEPLOYMENT ROD, AND WOULD NOT RETRACT TO ALLOW THE SECOND ANCHOR TO DEPLOY. THE REP CONFIRMED THAT THE FIRST ANCHOR FROM BOTH AR-4502 (LOT: 10056961 & LOT: 10135406 X1) DEPLOYED SUCCESSFULLY, AND WERE NOT RETRIEVED. THE THIRD AR-4502 (LOT: 10135406) HAD A TRIGGER THAT WAS FIRMLY LOCKED AND WOULD NOT ALLOW PASSAGE OF THE SECOND ANCHOR. THE REP C

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8107635 ↗
• InjuryOct 1, 2018Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR PROCEDURE, THE SURGEON WAS USING A SPEED CINCH, AR-4502, LOT: 10175535. THE SURGEON IMPLANTED THE FIRST IMPLANT WITH NO INCIDENT. WHEN HE WENT TO INSERT THE SECOND IMPLANT, THE SECOND IMPLANT WOULD NOT DEPLOY. THE SURGEON REMOVED THE FIRST IMPLANT WITH A PAIR OF GRASPERS AND OPENED UP A SECOND SPEED CINCH, AR-4502, LOT: 10184671. THE FIRST IMPLANT DEPLOYED AND SEATED WITH NO ISSUE BUT AGAIN, THE SECOND IMPLANT DID NOT DEPLOY. THE SURGEON REMOVED THE FIRST IMPLANT WITH GRASPERS AND SWITCHED TO A MENISECTOMY INSTEAD.

  Patient problems: No Code Available

  MAUDE report 7922613 ↗
• InjuryOct 1, 2018Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR PROCEDURE, THE SURGEON WAS USING A SPEED CINCH, AR-4502, LOT: 10175535. THE SURGEON IMPLANTED THE FIRST IMPLANT WITH NO INCIDENT. WHEN HE WENT TO INSERT THE SECOND IMPLANT, THE SECOND IMPLANT WOULD NOT DEPLOY. THE SURGEON REMOVED THE FIRST IMPLANT WITH A PAIR OF GRASPERS AND OPENED UP A SECOND SPEED CINCH, AR-4502, LOT: 10184671. THE FIRST IMPLANT DEPLOYED AND SEATED WITH NO ISSUE BUT AGAIN, THE SECOND IMPLANT DID NOT DEPLOY. THE SURGEON REMOVED THE FIRST IMPLANT WITH GRASPERS AND SWITCHED TO A MENISECTOMY INSTEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7922599 ↗
• InjuryJun 22, 2018Break; Positioning Failure

  IT WAS REPORTED BY THE REP THAT DURING THE CASE, AFTER THE FIRST IMPLANT DEPLOYED, THE HANDLE FELL APART. THE FIRST ANCHOR REMAINS IN THE SOFT TISSUE; THE SECOND ANCHOR WAS NOT DEPLOYED. A COMPETITOR'S DEVICE WAS USED TO COMPLETE THE CASE. PATIENT IS A (B)(6) YEAR OLD FEMALE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7629117 ↗
• InjuryJan 31, 2018Material Separation; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, AFTER THE SURGEON PRESSED #1 AND INSERTED THE SPEED CINCH INTO THE JOINT, HE SQUEEZED THE TRIGGER AND IT GOT STUCK, HE SQUEEZED AGAIN AND THE DEVICE FELL APART. THE FIRST ANCHOR DEPLOYED AND SEATED. THE SURGEON CUT THE SUTURE AND TIED THE IMPLANT DOWN, COMPLETING THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7230318 ↗
• InjuryJan 31, 2018Break

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR PROCEDURE, THE SURGEON INSERTED AND FIRED THE FIRST IMPLANT AND THE ANCHOR SEATED SUCCESSFULLY, HOWEVER, WHEN HE WENT TO FIRE THE SECOND IMPLANT, THE DISTAL END OF THE SPEED CINCH BROKE OFF. THE FIRST IMPLANT AND ALL OF ITS SUTURE WAS REMOVED FROM THE MENISCUS AND THE SURGEON PERFORMED A MENISECTOMY INSTEAD. FOLLOW-UP INVESTIGATION: THE TIP OF THE CINCH WAS RETRIEVED BUT WAS DISCARDED AND WILL NOT BE RETURNED.

  Patient problems: No Code Available

  MAUDE report 7230316 ↗
• InjuryDec 15, 2017Positioning Failure; Mechanical Jam

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE, THE TRIGGER ON THE SPEED CINCH LOCKED UP AFTER THE SURGEON ATTEMPTED TO DEPLOY THE SECOND IMPLANT. A SECOND SPEED CINCH OF THE SAME LOT NUMBER WAS USED AND THE FIRST IMPLANT WAS SUCCESSFULLY DEPLOYED, HOWEVER, WHEN THE SURGEON WENT TO DEPLOY THE SECOND IMPLANT, THE TRIGGER JAMMED AND THE IMPLANT DID NOT DEPLOY. THE INCIDENT REPORT STATES THAT IMPLANTS WERE LEFT IN THE PATIENT'S MENISCUS. *ADDITIONAL INFORMATION HAS BEEN REQUESTED. PATIENT IS A FEMALE, (B)(6). FOLLOW-UP INFORMATION: IMPLANT NUMBER ONE FROM THE FIRST DEVICE WAS LEFT IN THE PATIENT. THE CASE WAS COMPLETED WITH 4 OF THE OLDER VERSION MENISCAL CINCH (AR-4500). THE COMPLAINT DEVICES WERE DISPOSED OF IN THE SHARPS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7120782 ↗
• InjuryNov 14, 2017Break; Disassembly

  IT WAS REPORTED THAT DURING A RIGHT MENISCAL REPAIR PROCEDURE, THE SURGEON INTRODUCED THE SPEED CINCH INTO THE KNEE. WHEN HE INSERTED THE CINCH, THE SURGEON WAS UNABLE TO GET THROUGH THE MENISCUS AND AS HE TRIED TO INSERT THE CINCH, THE DEVICE FELL APART WHERE THE NEEDLE SHAFT MEETS THE ACTUAL DEVICE. THE SURGEON DID NOT BOTHER WITH A SECOND SPEED CINCH, INSTEAD HE PERFORMED A MENISECTOMY. PATIENT IS A MALE, (B)(6). FOLLOW-UP INVESTIGATION: THE SPEEDCINCH BROKE INTO 2 PIECES WITH THE SHAFT/TIP BREAKING WHILE INSIDE THE KNEE. EVERYTHING WAS RETRIEVED. THE BROKEN DEVICE PIECES WERE DISCARDED BEFORE THEY WERE ABLE TO BE RETRIEVED TO RETURN FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7027719 ↗
• InjuryOct 18, 2017Positioning Failure

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR FOR A LARGE BUCKET HANDLE TEAR, THE FIRST AR-4502 WENT IN SUCCESSFULLY. AS THE SURGEON WORKED AROUND THE RIM OF THE TEAR, THERE WERE FOUR UNSUCCESSFUL ATTEMPTS. THE 2ND AND 3RD DEVICE, THE FIRST IMPLANT DEPLOYED BUT THE SECOND WOULD NOT. THE FIRST IMPLANTS WERE REMOVED. WITH THE 4TH DEVICE, THE SUTURE TORE DURING CINCHING. THE SECOND IMPLANT WAS REMOVED; THE FIRST IMPLANT REMAINS IN THE PATIENT. WITH THE FIFTH DEVICE, THE SECOND IMPLANT WOULD NOT DEPLOY. THE CASE WAS COMPLETED WITH AN OUTSIDE/IN TECHNIQUE WITH #2 FIBERWIRE. THERE WERE NO REPS PRESENT IN THE CASE. ADDITIONAL INFORMATION RECEIVED: THE FIRST IMPLANT OF THE FIFTH DEVICE WAS COMPLETELY REMOVED. PATIENT WAS A (B)(6) YEAR OLD FEMALE.

  Patient problems: No Information

  MAUDE report 6958014 ↗
• InjuryOct 10, 2017Positioning Failure

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION WITH MENISCAL REPAIR PROCEDURE, THE SURGEON WAS ATTEMPTING TO USE A SPEED CINCH W/ 2 PEEK IMPLANTS. THE SURGEON FULLY SQUEEZED THE TRIGGER, HOWEVER, THE FIRST IMPLANT DID NOT DEPLOY. HE SQUEEZED A SECOND TIME, AND STILL, THE IMPLANT DID NOT DEPLOY. A SECOND SPEED CINCH OF THE SAME LOT NUMBER WAS OPENED AND USED. THE FIRST IMPLANT ON THIS SPEED CINCH WAS SUCCESSFULLY IMPLANTED, BUT, WHEN THE SURGEON ATTEMPTED TO DEPLOY THE SECOND IMPLANT, THE IMPLANT DID NOT DEPLOY. THE REP IS UNSURE IF THE FIRST IMPLANT WAS REMOVED FROM THE MENISCUS. THE CASE WAS COMPLETED WITH AN AR-4500 MENISCAL CINCH. PATIENT IS A MALE.

  Patient problems: No Code Available

  MAUDE report 6934419 ↗
• InjuryAug 23, 2017Break

  IT WAS REPORTED THAT DURING IMPLANT, THE METAL TIP AT END OF THE IMPLANT SNAPPED. IT WAS RETRIEVED FROM THE PATIENT; A MENISCECTOMY WAS PERFORMED TO COMPLETE THE CASE. ACL/MENISCAL REPAIR. A (B)(6) MALE. FOLLOW-UP INVESTIGATION: IT WAS REPORTED THAT DURING THE IMPLANTATION, THE METAL TIP ENTERED THROUGH THE MENISCUS AND SNAPPED UPON RETRIEVAL. THE "METAL TIP" REFERS TO THE END OF THE DELIVERY MECHANISM AND NOT THE IMPLANT ITSELF. THE SURGICAL TECHNIQUE CHANGED TO A MENISCECTOMY DUE TO THE SURGICAL TIME FRAME AND THE SURGEON MADE THE DECISION TO MOVE ON WITHOUT USING A SPEEDCINCH.

  Patient problems: No Information

  MAUDE report 6812728 ↗
• InjuryAug 1, 2017Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING AN ACL W/ MENISCAL REPAIR PROCEDURE, THE SURGEON WAS USING A SPEED CINCH W/ 2 PEEK IMPLANTS (LOT: 10135406). THE FIRST IMPLANT WAS IMPLANTED SUCCESSFULLY HOWEVER, THE SURGEON IS UNSURE IF THE SECOND IMPLANT DEPLOYED OR NOT. THE SURGEON STATED THAT THE DEPLOYMENT FELT SMOOTH BUT CANNOT CONFIRM IF THE IMPLANT WAS IMPLANTED AS HE DID NOT TIE THEM TOGETHER. THE SUTURE ENDED UP ON THE SURGEON'S HAND WHEN HE PULLED ON THEM. HE SWITCHED TO A DEVICE FROM A DIFFERENT MANUFACTURER AND THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT. ARTHREX SALES REPRESENTATIVE WAS PRESENT FOR THE CASE. THERE ARE NO PLANS FOR A SECOND SURGERY TO REMOVE THE UNRETRIEVED DEVICE FRAGMENTS. NO PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 6756596 ↗
• InjuryJul 25, 2017Break; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE FIRST IMPLANT DEPLOYED; WITH THE SECOND IMPLANT, IT CAME BACK OUT OF THE MENISCUS WHEN SECURING WITH THE KNOT PUSHER. THE FIRST IMPLANT REMAINS IN THE PATIENT. THE SECOND SPEED CINCH WAS SUCCESSFUL. WITH THE THIRD AND FOURTH SPEED CINCHES, THE FIRST IMPLANT WAS SUCCESSFUL; WITH THE SECOND IMPLANT, THE TIP OF THE DEVICE BROKE WHEN THE SURGEON LEVERAGED IT UP AGAINST THE CONDYLE; THE SECOND IMPLANT DID NOT IMPLANT. THOSE FIRST IMPLANTS ALSO REMAIN IN THE PATIENT. PATIENT FEMALE, 20S. FOLLOW-UP INVESTIGATION: THE 3RD SPEED CINCH LOST BOTH IMPLANTS AND WERE NOT ABLE TO BE RECOVERED FROM PATIENT. AFTER THE 4TH SPEED CINCH FAILED THE CASE WAS COMPLETED USING ANOTHER MANUFACTURE'S DEVICE.

  Patient problems: No Information

  MAUDE report 6739488 ↗
• InjuryJun 26, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR PROCEDURE, THE SURGEON WAS ATTEMPTING TO USE A SPEED CINCH W/ 2 PEEK IMPLANTS. DURING USE, AFTER THE FIRST IMPLANT HAD ALREADY BEEN IMPLANTED, THE HANDLE WOULD NOT RELEASE THE SECOND IMPLANT. NO FURTHER INFORMATION HAS BEEN OBTAINED.

  Patient problems: No Information

  MAUDE report 6667373 ↗
• InjuryJun 9, 2017Misfire

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR PROCEDURE, THE AR-4502, SPEED CINCH, LOT: 10023651 ((B)(4)) DID NOT FUNCTION PROPERLY. THE SPEED CINCH SUCCESSFULLY DEPLOYED AND IMPLANTED THE FIRST IMPLANT HOWEVER, THE SPEED CINCH MISFIRED ON THE SECOND IMPLANT. THE FIRST IMPLANT WAS REMOVED AND A SECOND SPEED CINCH OF A DIFFERENT LOT, LOT: 10048688 ((B)(4)) WAS OPENED AND AGAIN, THE SPEED CINCH SUCCESSFULLY DEPLOYED AND IMPLANTED THE FIRST IMPLANT HOWEVER, THE CINCH MISFIRED ON THE SECOND IMPLANT. THE FIRST IMPLANT WAS REMOVED HOWEVER, THE SURGEON WAS UNABLE TO REPAIR THE PATIENT'S MENISCUS AND HE ENDED UP CONVERTING TO A MENISECTOMY. THE SURGEON STATED THAT HE'S BRINGING THE PATIENT BACK FOR AN ACL RECONSTRUCTION AND WILL REASSESS THE MENISCUS INTRA-OPERATIVELY.

  Patient problems: No Code Available

  MAUDE report 6631078 ↗
• InjuryJun 9, 2017Misfire; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR PROCEDURE, THE AR-4502, SPEED CINCH, LOT: 10023651 ((B)(4)) DID NOT FUNCTION PROPERLY. THE SPEED CINCH SUCCESSFULLY DEPLOYED AND IMPLANTED THE FIRST IMPLANT HOWEVER, THE SPEED CINCH MISFIRED ON THE SECOND IMPLANT. THE FIRST IMPLANT WAS REMOVED AND A SECOND SPEED CINCH OF A DIFFERENT LOT, LOT: 10048688 ((B)(4)) WAS OPENED AND AGAIN, THE SPEED CINCH SUCCESSFULLY DEPLOYED AND IMPLANTED THE FIRST IMPLANT HOWEVER, THE CINCH MISFIRED ON THE SECOND IMPLANT. THE FIRST IMPLANT WAS REMOVED HOWEVER, THE SURGEON WAS UNABLE TO REPAIR THE PATIENT'S MENISCUS AND HE ENDED UP CONVERTING TO A MENISECTOMY. THE SURGEON STATED THAT HE'S BRINGING THE PATIENT BACK FOR AN ACL RECONSTRUCTION AND WILL REASSESS THE MENISCUS INTRA-OPERATIVELY.

  Patient problems: No Code Available

  MAUDE report 6631072 ↗
• InjuryApr 25, 2017Positioning Failure

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR PROCEDURE, THE SURGEON WAS ATTEMPTING TO USE A SPEED CINCH W/ 2 PEEK IMPLANTS. THE FIRST SPEED CINCH, LOT: 10048687, ((B)(4)) WAS INSERTED INTO THE MENISCUS AND THE SURGEON WAS ABLE TO SUCCESSFULLY IMPLANT THE FIRST IMPLANT HOWEVER, WHEN THE SURGEON PULLED THE TRIGGER TO RELEASE THE SECOND IMPLANT, IT DID NOT DEPLOY. THE SUTURE WAS CUT AND THE FIRST IMPLANT WAS REMOVED WITH GRASPERS. A SECOND SPEED CINCH OF THE SAME LOT, LOT: 10048687 ((B)(4)) WAS USED AND AGAIN THE FIRST IMPLANT DEPLOYED AND SEATED FINE BUT WHEN THE SURGEON PULLED THE TRIGGER TO RELEASE THE SECOND IMPLANT, IT DID NOT DEPLOY. THE SUTURE WAS CUT AND THE FIRST IMPLANT WAS REMOVED WITH GRASPERS. A THIRD SPEED CINCH OF A DIFFERENT LOT, LOT: 10048688 ((B)(4)) WAS OPENED AND USED AND THE EXACT SAME THING HAPPENED, THE SURGEON WAS ABLE TO SUCCESSFULLY IMPLANT THE FIRST IMPLANT HOWEVER, WHEN THE SURGEON PULLED THE TRIGGER TO RELEASE THE SECOND IMPLANT, IT DID NOT DEPLOY. THE SUTURE WAS CUT AND THE FIRST IMPLANT WAS REMOVED WITH GRASPERS. THE SURGEON THEN CONVERTED TO A MINI MENISECTOMY. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6520077 ↗
• InjuryApr 25, 2017Positioning Failure

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR PROCEDURE, THE SURGEON WAS ATTEMPTING TO USE A SPEED CINCH W/ 2 PEEK IMPLANTS. THE FIRST SPEED CINCH, LOT: 10048687, (CC111474 LINE 189734) WAS INSERTED INTO THE MENISCUS AND THE SURGEON WAS ABLE TO SUCCESSFULLY IMPLANT THE FIRST IMPLANT HOWEVER, WHEN THE SURGEON PULLED THE TRIGGER TO RELEASE THE SECOND IMPLANT, IT DID NOT DEPLOY. THE SUTURE WAS CUT AND THE FIRST IMPLANT WAS REMOVED WITH GRASPERS. A SECOND SPEED CINCH OF THE SAME LOT, LOT: 10048687 (CC111474 LINE 189734) WAS USED AND AGAIN THE FIRST IMPLANT DEPLOYED AND SEATED FINE BUT WHEN THE SURGEON PULLED THE TRIGGER TO RELEASE THE SECOND IMPLANT, IT DID NOT DEPLOY. THE SUTURE WAS CUT AND THE FIRST IMPLANT WAS REMOVED WITH GRASPERS. A THIRD SPEED CINCH OF A DIFFERENT LOT, LOT: 10048688 (CC111474 LINE 189735) WAS OPENED AND USED AND THE EXACT SAME THING HAPPENED, THE SURGEON WAS ABLE TO SUCCESSFULLY IMPLANT THE FIRST IMPLANT HOWEVER, WHEN THE SURGEON PULLED THE TRIGGER TO RELEASE THE SECOND IMPLANT, IT DID NOT DEPLOY. THE SUTURE WAS CUT AND THE FIRST IMPLANT WAS REMOVED WITH GRASPERS. THE SURGEON THEN CONVERTED TO A MINI MENISECTOMY. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6520054 ↗
• InjuryApr 25, 2017Break; Positioning Failure; Entrapment of Device; Mechanical Jam

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR PROCEDURE, THE SURGEON WAS ATTEMPTING TO USE A SPEED CINCH W/ 2 PEEK IMPLANTS. THE FIRST SPEED CINCH (LOT: 10048688, LINE 189642) SNAPPED AT THE TIP UPON INSERTION INTO THE MENISCUS FOR THE FIRST TIME. THE SPEED CINCH TIP WAS HANGING ON BY A THREAD WHEN THE DEVICE WAS RETRACTED FROM THE KNEE. A SECOND SPEED CINCH OF THE SAME LOT (LOT: 10048688, LINE 189642) WAS OPENED AND USED AND AGAIN, UPON INSERTION INTO THE MENISCUS TO INSERT AND SEAT THE FIRST IMPLANT, THE TIP SNAPPED AND WAS BARELY HANGING ON. THE SPEED CINCH WAS DISCARDED AND A THIRD SPEED CINCH OF THE SAME LOT (LOT: 10048688, LINE 189642) WAS OPENED AND AGAIN, BROKE ON INSERTION LEAVING THE TIP HANGING. THE SPEED CINCH WAS DISCARDED AND A FOURTH SPEED CINCH, THIS TIME OF A DIFFERENT LOT (10048684, LINE 189643), WAS OPENED AND THE SURGEON WAS ABLE TO SUCCESSFULLY SEAT THE FIRST IMPLANT HOWEVER, WHEN THE SURGEON WENT TO FIRE THE SECOND IMPLANT, THE IMPLANT DID NOT DEPLOY CORRECTLY AND PULLED RIGHT OUT OF THE MENISCUS. THE SURGEON CUT THE SUTURE AND TIED THE IMPLANT, LEAVING IT IN THE MENISCUS. A FIFTH SPEED CINCH OF THE SAME LOT (10048684, LINE 189643) WAS OPENED AND USED AND AGAI

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6520045 ↗
• InjuryApr 25, 2017Break; Positioning Failure; Activation, Positioning or Separation Problem; Mechanical Jam

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR PROCEDURE, THE SURGEON WAS ATTEMPTING TO USE A SPEED CINCH W/ 2 PEEK IMPLANTS. THE FIRST SPEED CINCH (LOT: 10048688, LINE (B)(4)) SNAPPED AT THE TIP UPON INSERTION INTO THE MENISCUS FOR THE FIRST TIME. THE SPEED CINCH TIP WAS HANGING ON BY A THREAD WHEN THE DEVICE WAS RETRACTED FROM THE KNEE. A SECOND SPEED CINCH OF THE SAME LOT (LOT: 10048688, LINE (B)(4)) WAS OPENED AND USED AND AGAIN, UPON INSERTION INTO THE MENISCUS TO INSERT AND SEAT THE FIRST IMPLANT, THE TIP SNAPPED AND WAS BARELY HANGING ON. THE SPEED CINCH WAS DISCARDED AND A THIRD SPEED CINCH OF THE SAME LOT (LOT: 10048688, LINE (B)(4)) WAS OPENED AND AGAIN, BROKE ON INSERTION LEAVING THE TIP HANGING. THE SPEED CINCH WAS DISCARDED AND A FOURTH SPEED CINCH, THIS TIME OF A DIFFERENT LOT (10048684, LINE (B)(4)), WAS OPENED AND THE SURGEON WAS ABLE TO SUCCESSFULLY SEAT THE FIRST IMPLANT HOWEVER, WHEN THE SURGEON WENT TO FIRE THE SECOND IMPLANT, THE IMPLANT DID NOT DEPLOY CORRECTLY AND PULLED RIGHT OUT OF THE MENISCUS. THE SURGEON CUT THE SUTURE AND TIED THE IMPLANT, LEAVING IT IN THE MENISCUS. A FIFTH SPEED CINCH OF THE SAME LOT (10048684, LINE (B)(4)) WAS OPENED AND USED AND AGAI

  Patient problems: No Information

  MAUDE report 6520043 ↗