SPEEDTRAP 223746Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10886705027132), received between Mar 16, 2018 and Jul 13, 2026 — classified as 4 injuries, 36 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, 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 40 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED SEPTIC INFECTION AFTER ACL (ANT.CRUCIATE LIGAMENT) RECONSTRUCTION SURGERY WHERE J&J IMPLANTS (DYNACORD X1, SPEEDTRAP X4, MILAGRO X1, RIGIDLOOP X1, ABSOLUTE X1) WERE UTILIZED. THE INITIAL ACL CASE TOOK PLACE ON (B)(6) 2026. DURING THE CASE, THERE WAS NO NOTABLE INCIDENT OBSERVED, ALL PROCEDURES FOLLOWED HOSPITAL POLICY AND THE CASE DURATION WAS APPROXIMATELY 1.5 HOURS. AFTER SURGERY, PATIENT VISITED THE SURGEON FOR CONSULTATION AND SURGEON PRESCRIBED ANTIBIOTICS AND CLEANED WOUND. AS SITUATION WAS NOT IMPROVED, A SECOND SURGERY WAS ARRANGED ON (B)(6) 2026 TO REMOVE ALL IMPLANTS AND WASHED THE JOINT WITH ANTIBIOTICS. ALL IMPLANTS WERE DISCARDED ON (B)(6) 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. REPORT 7 OF 8 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 25796238 ↗
• InjuryJul 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED SEPTIC INFECTION AFTER ACL (ANT.CRUCIATE LIGAMENT) RECONSTRUCTION SURGERY WHERE J&J IMPLANTS (DYNACORD X1, SPEEDTRAP X4, MILAGRO X1, RIGIDLOOP X1, ABSOLUTE X1) WERE UTILIZED. THE INITIAL ACL CASE TOOK PLACE ON (B)(6) 2026. DURING THE CASE, THERE WAS NO NOTABLE INCIDENT OBSERVED, ALL PROCEDURES FOLLOWED HOSPITAL POLICY AND THE CASE DURATION WAS APPROXIMATELY 1.5 HOURS. AFTER SURGERY, PATIENT VISITED THE SURGEON FOR CONSULTATION AND SURGEON PRESCRIBED ANTIBIOTICS AND CLEANED WOUND. AS SITUATION WAS NOT IMPROVED, A SECOND SURGERY WAS ARRANGED ON (B)(6) 2026 TO REMOVE ALL IMPLANTS AND WASHED THE JOINT WITH ANTIBIOTICS. ALL IMPLANTS WERE DISCARDED ON (B)(6) 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. REPORT 2 OF 8 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 25796223 ↗
• MalfunctionMar 3, 2026Mechanical Jam

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE THAT THE SPEEDTRAP WHITE 20MM DEVICE THAT THE STUMP OF THE GRAFT WAS CLAMPED WITH THE SPEEDTRAP AND THE SUTURE WAS PULLED, BUT IT WAS VERY TIGHT AND THE LAST SUTURE COULD NOT BE REMOVED FROM THE DEVICE. ALL OF THE SPEEDTRAP THREADS WERE REMOVED AND A DIFFERENT SPEEDTRAP WAS USED TO RETHREAD THE SUTURES, WHICH ALLOWED THE GRAFT TO BE FIXED WITHOUT ANY PROBLEMS. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24503135 ↗
• MalfunctionDec 18, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE SPEEDTRAP WHITE 20MM DEVICE FAILED TO TRAP THE GRAFT PROPERLY AND THE SUTURE TANGLED UP DURING TIGHTENING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838871 ↗
• MalfunctionDec 10, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE, THE SPEEDTRAP WHITE 20MM DEVICE SUTURE OF THE SPEED TRAP WAS TORN (CONSTRUCT BREAK DOWN) WHEN TRYING TO USE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769780 ↗
• MalfunctionOct 15, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE SPEEDTRAP WHITE 20MM DEVICE CAME LOOSE WHEN IT WAS USED DURING SURGERY. ANOTHER PRODUCT WAS USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301690 ↗
• MalfunctionJun 12, 2025Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE SUTURE FROM THE SPEEDTRAP WHITE 20 MM DEVICE SNAPPED WHILE THE GRAFT WAS BEING THREADED THROUGH THE BURR HOLE AS THE FINAL STEP. IT WAS ALSO INDICATED THAT RETRACTION TOWARDS THE TIBIA WAS CHALLENGING. WHILE THERE WAS TENSION ON THE SUTURE THAT CAUSED IT TO FLIP, IT WAS NOT BEING SUBJECTED TO EXCESSIVE PULLING. ALTHOUGH THE GRAFT SUTURE AREA DID NOT WEAKEN, RELYING ON ONLY ONE SUTURE FOR FIXATION PRESENTED SOME CHALLENGES. THE SURGEON EFFECTIVELY MANAGED THE SITUATION AND SUCCESSFULLY COMPLETED THE SURGERY. THERE WAS THIRTY-MINUTE DELAY TO THE SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22193780 ↗
• MalfunctionJan 3, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE SPEEDTRAP WHITE 20MM DEVICE SUTURE OF THE PRODUCT IN QUESTION INTERFERED WITH ANOTHER IMPLANT AND BROKE. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21066189 ↗
• MalfunctionNov 25, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE SURGEON KNOTTED THE ENDS OF THE SPEEDTRAP WHITE 20MM DEVICE AND THE SUTURE BROKE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20770819 ↗
• MalfunctionJul 8, 2024Break; Break

  IT WAS REPORTED FROM HONG KONG THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE SPEEDTRAP WHITE 20MM DEVICE BROKE DURING TENDON STRIPPING. THEN ALL THE BROKEN PARTS WERE REMOVED. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19696863 ↗
• MalfunctionMar 6, 2024Crack; Crack

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE SPEEDTRAP WHITE 20MM DEVICE BECAME FRAYED AND TANGLED; THEREFORE, COULD NOT BE USED FOR SURGERY. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18850674 ↗
• MalfunctionFeb 21, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING A ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT TEAR ARTHROPLASTY FOR ACLT SURGICAL PROCEDURE ON (B)(6) 2024 THE 2X SPEEDTRAP WHITE DEVICES COULD NOT BE USED FOR SURGERY. ALTHOUGH THE GRAFT WAS LOADED INTO THE FIRST SPEEDTRAP, THE TISSUE WAS TOO THICK TO WRAP PROPERLY AND COULD NOT BE USED. THE SURGEON WAS ABLE TO WRAP THE GRAFT WITH THE SPEEDTRAP AND GRAFT FIXING WITH NO PROBLEM. HOWEVER, THE SUTURE BROKE DURING SCREW FIXATION ON THE TIBIAL SIDE AFTER INSERTION OF THE GRAFTED TENDON AND FIXATION ON THE FEMORAL SIDE. THE TIBIAL SIDE COULD NOT BE FIXED. A NEW SAME DEVICE WAS USED FOR SURGERY. GRAFTING WAS PERFORMED BY ASSISTANT SURGEON, AND THE CAUSE OF SUTURE BREAKAGE WAS IDENTIFIED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A THIRTY MINUTE DELAY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18747696 ↗
• MalfunctionFeb 21, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING A ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT TEAR ARTHROPLASTY FOR ACLT SURGICAL PROCEDURE ON (B)(6) 2024 THE 2X SPEEDTRAP WHITE DEVICES COULD NOT BE USED FOR SURGERY. ALTHOUGH THE GRAFT WAS LOADED INTO THE FIRST SPEEDTRAP, THE TISSUE WAS TOO THICK TO WRAP PROPERLY AND COULD NOT BE USED. THE SURGEON WAS ABLE TO WRAP THE GRAFT WITH THE SPEEDTRAP AND GRAFT FIXING WITH NO PROBLEM. HOWEVER, THE SUTURE BROKE DURING SCREW FIXATION ON THE TIBIAL SIDE AFTER INSERTION OF THE GRAFTED TENDON AND FIXATION ON THE FEMORAL SIDE. THE TIBIAL SIDE COULD NOT BE FIXED. A NEW SAME DEVICE WAS USED FOR SURGERY. GRAFTING WAS PERFORMED BY ASSISTANT SURGEON, AND THE CAUSE OF SUTURE BREAKAGE WAS IDENTIFIED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A THIRTY MINUTE DELAY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18747688 ↗
• MalfunctionDec 26, 2023Break; Break

  IT WAS REPORTED BY AN AFFILIATE THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION (ACLR) SURGICAL PROCEDURE PERFORMED ON THE RIGHT KNEE ON (B)(6) 2023 WHILE USING THE SPEEDTRAP WHITE DEVICE THE SURGEON LIGHTLY PULLED THE SUTURE RIM, THE SPINE SUTURE TORE OFF AND IT WAS NOT POSSIBLE TO THREAD THE GRAFT. A NEW SAME PRODUCT WAS USED FOR SURGERY. THERE WAS NO BROKEN PIECE IN THE BODY. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18394850 ↗
• MalfunctionJul 27, 2023Migration; Migration

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE SPEEDTRAP CONSTRUCT  WHITE, SHORT DEVICE CAME OFF FROM THE TENDON UPON INSERTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17407611 ↗
• MalfunctionJun 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY SALES REP THAT DURING A MEDIAL PATELLOFEMORAL LIGAMENT (MPFL) REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE SUTURE SWEPT OFF FROM SPEEDTRAP CONSTRUCT  WHITE, SHORT DEVICE AS THEY WEREN'T ATTACHED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17154890 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON AN UNKNOWN DATE, A SPEEDTRAP CONSTRUCT  WHITE, SHORT DEVICE WAS USED. ACCORDING TO THE REPORT, ONE MONTH AFTER SURGERY, INFLAMMATION AND FEVER OCCURRED IN THE KNEE JOINT. IT WAS REPORTED THAT WHEN THE INFLAMED SYNOVIUM WAS REMOVED BY ARTHROSCOPE, THERE WAS A LOT OF SYNOVIAL MEMBRANE AROUND THE DEVICE. IT WAS REPORTED THAT THERE ARE NO ABNORMALITIES WHEN IT WAS SENT TO PATHOLOGY FOR NOW. IT WAS REPORTED THAT ALTHOUGH THERE WERE SIGNS OF INFECTION, IT COULD BE RULED OUT AS A COMPLETE INFECTION. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 16765119 ↗
• MalfunctionFeb 21, 2023Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE KNOT OF A SPINE SUTURE CUT INTO THE SLIT OF THE SPEEDTRAP CONSTRUCT  WHITE, SHORT DEVICE, AND THE SPINE SUTURE COULD NOT BE REMOVED. ACCORDING TO THE REPORT, THE ASSISTANT SURGEON BROKE THE SPEEDTRAP WITH A PIN CUTTER AND REMOVED THE SPINE SUTURE FROM THE SPEEDTRAP. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16411021 ↗
• MalfunctionDec 19, 2022Migration; Migration

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE SPEEDTRAP CONSTRUCT WHITE, SHORT AND THE SPEEDTRAP CONSTRUCT GREEN/WHITE, SHORT DEVICES WOULD NOT STAY IN THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16007464 ↗
• MalfunctionDec 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE MOST DISTAL AND CROSSED SUTURE ON THE SPEEDTRAP WHITE 20MM DEVICE CAME OFF THE GRAFT WHILE THE SURGEON WAS WRAPPING THE GRAFT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12971908 ↗
• MalfunctionAug 3, 2021Crack; Material Deformation; Crack; Material Deformation

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE SPEEDTRAP WHITE 20MM SUTURE DEVICE TANGLED WITH THE GRAFT GRASPER THEN GOT DAMAGED WHEN THE GRAFT SLIPPED FROM THE GRAFT GRASPER. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHIN 30 MINUTES OF DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE WAS THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12267066 ↗
• MalfunctionJun 21, 2021Crack; Crack

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE SPEEDTRAP WHITE 20MM SUTURE DEVICE SNAPPED AS IT WAS STRETCHED FROM THE FIXATION AT THE FEMORAL SIDE TO THE TIBIAL SIDE. THE SNAPPED GRAFTS WERE THEN SHORTENED BUT WAS USED TO COMPLETE THE FIXATION. THE PROCEDURE WAS COMPLETED WITH LESS THAN 30-MINUTE SURGICAL DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12033751 ↗
• MalfunctionFeb 26, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION THE GRAFT WAS BEING HELD WITH TENSION, WHILE THE SURGEON WAS SOMEWHAT APPLYING THE SUTURE WITH THE SPEEDTRAP WHITE 20 MM THE GRAFT WAS PULLED BACK. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. AS ADDITIONAL INFORMATION, THE SURGEON MENTIONED THIS WAS THE THINNEST LIGAMENT THE S/HE HAD SEEN. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE DEVICE WILL NOT BE RETURNING FOR EVALUATION. ADDITIONAL INFORMATION WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9759237 ↗
• MalfunctionJan 30, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT WHEN THE PACKAGE OF THE SPEEDTRAP WHITE SHORT 20MM WAS OPEN THE STERILE NURSE WAS TAKING THE INSTRUCTION PAPER. WHEN THE SURGE WAS DOING THAT, THE SUTURE OF THE SPEEDTRAP WHITE SHORT 20MM FELL TO THE BORDER OF THE PACKAGE, THE NURSE IS COMPLAINING THAT THE SUTURE SHOULD BE HIDDEN UNDER THE PLASTIC OF THE SPEEDTRAP WHITE SHORT 20MM, BECAUSE IT IS TOO RISKY WHEN MAKING THE STERILIZATION. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9650084 ↗
• MalfunctionDec 9, 2019Disconnection; Disconnection

  IT WAS REPORTED BY THE AFFILIATE THAT DURING AN UNKNOWN PROCEDURE WHEN THE PAPER SHEET ON THE UNIT WAS REMOVED THE SPEEDTRAP WHITE 20MM WAS ALSO PICKED TOGETHER AND FELL OF THE UNIT. AS PER THE AFFILIATE THIS WAS THE FIRST USED. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED THE PROCEDURE WAS SUCCESSFULLY COMPLETED BUT ADDITIONAL DETAILS ABOUT THE PROCEDURE COULD NOT BE PROVIDED. THE AFFILIATE ALSO REPORTED THE DEVICE WOULD NOT BE RETURNING TO MITEK FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9437157 ↗