SPEEDTRAP 223751Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10886705027972), received between Mar 12, 2018 and Jul 13, 2026 — classified as 5 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 48 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 8 OF 8 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 25796236 ↗
• 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 3 OF 8 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 25796225 ↗
• MalfunctionJun 8, 2026Break

  IT WAS REPORTED DURING AN UNKNOWN PROCEDURE, THE SPEEDTRAP FAILED. AFTER THE GRAFT WAS PULLED INTO THE JOINT AND FIXED FEMORALLY, THE DOCTORS WANTED TO KNOT THE SUTURES OF THE TIBIAL END OF THE GRAFT, WHICH WERE MOUNTED BY A SPEEDTRAP DEVICE, TO THE TIBIA THROUGH A SUTURE WASHER. THAT'S WHEN THEY NOTICED THAT 1 THREAD OF THE SPEEDTRAP HAD BROKEN. THEY HAD TO MAKE A SMALL INCISION ON THE THIGH TO REMOVE THE RIGIDLOOP ADJUSTABLE PLATE AND THEN TAKE THE GRAFT OUT THROUGH THE JOINT. THEN THEY RESEWED EVERYTHING WITH A NEW RLA AND SPEEDTRAP DEVICE AND FIXED EVERYTHING ANEW. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 20 MINUTE SURGICAL DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25425055 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE SUTURE OF SPEEDTRAP GRN/WHITE 20MM DEVICE WAS BROKEN WHEN TENSIONING FOR INSERTING THE INTRAFIX ADVANCE SCREW. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT, OR SURGICAL DELAY. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23020545 ↗
• MalfunctionMay 22, 2025Mechanical Problem; Unintended Movement; Mechanical Problem; Unintended Movement

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE SPEEDTRAP GRN/WHITE 20MM DEVICE BOTTOM SUTURE OF THE SPEED TRAP WAS LOOSE AS PER SURGEON, WHICH CAUSED THE SPEED TRAP TO SLIP OFF THE GRAFT WHEN TIGHTENED TO THE GRAFT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. 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 22070519 ↗
• MalfunctionJan 29, 2025Migration; Migration

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE SPEEDTRAP GRN/WHITE 20MM DEVICE WAS BEING USED WHEN THE DEVICE SLIPPED AND CAME OFF DURING GRAFT CREATION. ANOTHER PRODUCT WAS USED AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO PROBLEMS. SINCE IT WAS DISLODGED WHILE WORKING OUTSIDE THE BODY, THERE WERE NO REMAINS IN THE PATIENT'S BODY AND NO EFFECTS. 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 21263338 ↗
• MalfunctionOct 22, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED FROM CHINA THE SALES REP THAT PRIOR TO SURGERY, DURING STERILE PROCESSING IT WAS OBSERVED THAT THE SPEEDTRAP GRN/WHITE 20MM DEVICE BOX IMPLANT WAS MISSING AND HAD FOUR IFU BOOKLETS INSIDE. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20505819 ↗
• MalfunctionSep 25, 2024Migration; Migration

  IT WAS REPORTED FROM JAPAN THAT DURING WAS AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE FOR ANTERIOR CRUCIATE LIGAMENT (ACL) DAMAGE, IT WAS DISCOVERED THAT THE SPEEDTRAP GRN/WHITE 20MM DEVICE WAS REMOVED FROM THE BODY. DURING THE SURGERY, IT WAS REPORTED THAT THE SPEED TRAP WAS USED ON THE ¿AM¿ AND ¿PL¿ BUNDLES, RESPECTIVELY. AFTER GUIDING BOTH BUNDLES INTO THE BODY, TENSION WAS APPLIED TO EACH. UPON APPLYING TENSION, THE ¿PL¿ BUNDLE, ALONG WITH A PORTION OF THE GRAFT, WAS REMOVED FROM THE BODY. THE ¿PL¿ BUNDLE GRAFT WAS REMOVED, AND THE GRAFT, ALONG WITH PART OF THE ORIGINAL GRAFT AND THE DEVICE, WAS RE-SUTURED USING DIFFERENT THREADS TO FORM A NEW GRAFT. THIS GRAFT WAS THEN SUCCESSFULLY GUIDED BACK INTO THE BODY, ALONG WITH THE DEVICE. THERE WAS THIRTY-MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20302321 ↗
• MalfunctionJul 11, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN HONG KONG THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGICAL PROCEDURE ON (B)(6) 2024 IT WAS OBSERVED THAT WHEN THE SURGEON WAS PULLING THE SPEEDTRAP GRN/WHITE 20MM DEVICE SUTURES, THE SPEEDTRAP SUTURE WAS BROKEN. 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 19721091 ↗
• MalfunctionMay 9, 2024Migration; Migration

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE FOR THE KNEE WAS PERFORMED WHILE USING THE SPEEDTRAP GRN/WHITE 20MM DEVICE AFTER CREATING THE AM BUNDLE, THE PL BUNDLE WAS CREATED AS SAME PROCEDURE. THE BUTTON WAS FLIPPED AFTER PASSING THE GRAFT THROUGH THE BONE HOLE. WHEN THE DEVICE WAS PULLED TO APPLY TENSION, IT CAME OUT OF THE GRAFT AND OUT OF THE BODY. OTHER COMPANY¿S DEVICE WAS USED, AND THE GRAFT WAS CREATED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THERE WAS NO HARM TO THE PATIENT. THE DEVICE WORKED ON THE AM BUNDLE; HOWEVER, IT CAME LOOSE ON THE PL BUNDLE. ALTHOUGH ONE STITCH WAS MADE ON THE DISCONNECTED END SIDE BY ATTACHING THE DEVICE¿S SUTURE ON THE NEEDLE TO PREVENT DISLODGING, IT CAME LOOSE. THE DEVICE CAME OUT OF THE BODY, SO THAT THERE WERE NO PIECES IN THE BODY. THERE WAS NO PATIENT HARM REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19276841 ↗
• InjuryMar 21, 2024Migration; Migration

  IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY ON (B)(6) 2024, WHEN THE SPEEDTRAP GRN/WHITE 20MM DEVICE WAS USED TO REINFORCE THE TENDON, WHILE THE TENDON WAS PULLED THROUGH THE TIBIAL TUNNEL, THE SPEEDTRAP SUTURES SLID OFF THE IMPLANT AND HAD TO BE REMOVED.IT WAS REPORTED THAT THE KNEE HAD TO BE OPENED TO FINISH THE SURGERY AS IT WAS NOT POSSIBLE TO FINISH IT ARTHROSCOPICALLY. IT WAS REPORTED THAT FRAGMENTS WERE GENERATED BUT WERE REMOVED EASILY WITHOUT INTERVENTION. THERE WAS A TWENTY MINUTE DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18948630 ↗
• MalfunctionFeb 20, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 WHEN THE SPEEDTRAP DEVICE WAS PULLED IT DID NOT HANG ONTO THE GRAFT. THE SURGEON PULLED THE SUTURE FOR SEVERAL TIMES AND IT SNAPPED. A NEW SAME DEVICE WAS USED FOR SURGERY. THERE WAS NO SURGICAL DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18743499 ↗
• MalfunctionDec 14, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP IN HUNGARY THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE ON (B)(6) 2023 THE SPEEDTRAP DEVICE SHORT WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A FIVE MINUTE 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 18326399 ↗
• MalfunctionNov 20, 2023Delivered as Unsterile Product; Device Damaged Prior to Use; Delivered as Unsterile Product; Device Damaged Prior to Use

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN SWITZERLAND THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT ONE SUTURE ON THE SPEEDTRAP GRN/WHITE 20MM DEVICE WAS TRAPPED INTO THE PACKAGING; AND THEREFORE, IT WAS UNCLEAR IF IT WAS STERILE OR NOT. 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 18175822 ↗
• MalfunctionSep 26, 2023Migration; Migration

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, A SPEEDTRAP CONSTRUCT  GREEN/WHITE, SHORT DEVICE WAS USED FOR GRAFTING. ACCORDING TO THE REPORT, THE GRAFT CAME OUT INTO THE JOINT WHEN THE DEVICE WAS GUIDED INTO THE JOINT AND A COUNTER TENSION WAS APPLIED. IT WAS FURTHER REPORTED THAT IT WAS CONFIRMED THAT ONE SIDE OF THE GRAFT, WHICH HAD BEEN FOLDED IN TWO, HAD COME OFF THE DEVICE. THE DEVICE WAS REMOVED, AND GRAFTING WAS PERFORMED BY ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHIN 30 MINUTES DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17818353 ↗
• MalfunctionSep 5, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, A SPEEDTRAP CONSTRUCT  GREEN/WHITE, SHORT DEVICE WAS USED. ACCORDING TO THE REPORT, WHEN THE SURGEON PASSED THE SPEED TRAP THROUGH THE GRAFT AND PULLED THE SUTURE, THE SUTURE ITSELF GOT CAUGHT IN THE LOOP OF THE SUTURE AND THE SUTURE GOT TANGLED. 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 17684487 ↗
• MalfunctionMay 23, 2023Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, THE SPEEDTRAP CONSTRUCT  GREEN/WHITE, SHORT SNAPPED. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 45 MINUTES DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16985080 ↗
• MalfunctionMay 18, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP IN HONG KONG THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE SPEEDTRAP CONSTRUCT  GREEN/WHITE, SHORT DEVICE BROKE WHEN PULLED TO ATTACH 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16955602 ↗
• MalfunctionDec 19, 2022Migration; Migration

  THIS IS REPORT 2 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 16007469 ↗
• MalfunctionNov 4, 2022Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN FRANCE THAT DURING AN UNKNOWN SURGERY ON (B)(6)2022 , IT WAS OBSERVED THAT THE SPEEDTRAP CONSTRUCT  GREEN/WHITE, SHORT DEVICE BROKEN UPON TIGHTENING. 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 15729022 ↗
• MalfunctionAug 4, 2022Migration; Migration

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE SPEEDTRAP CONSTRUCT  GREEN/WHITE, SHORT SUTURE DEVICE CAME OFF THE GRAFT AS IT WAS PULLED FOR DEPLOYMENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH LESS THAN 30-MINUTE SURGICAL DELAY. 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 15164592 ↗
• MalfunctionJul 11, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ACLR (ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION) PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE SPEEDTRAP CONSTRUCT  GREEN/WHITE, SHORT SUTURE DEVICE SNAPPED WHEN THE GRAFT WAS PREPARED ON SEMITENDINOSUS BY SPEEDTRAP WITH A TIGHTENING. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14979876 ↗
• MalfunctionJan 12, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE OUTER PLASTIC CASE ON THE SPEEDTRAP GRN/WHITE 20MM DEVICE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. WITH LESS THAN 30-MINUTE SURGICAL DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES 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 13238118 ↗
• MalfunctionNov 29, 2021Migration; Migration

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE SPEEDTRAP GRN/WHITE 20MM SUTURE DEVICE SLIPPED FROM THE GRAFT WHEN THE SURGEON APPLIED TENSION TO 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 12886513 ↗
• InjuryJul 27, 2021Break; Break

  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 TENDON SNAPPED WHILE IN USE WITH THE RGDLOOP ADJUSTABLE STND DEVICE. SINCE THE TORN TENDON COULD NOT BE USED, RECONSTRUCTIVE SURGERY WAS PERFORMED USING GRACILIS, WITH ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE WITHOUT DELAY. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE WAS BRAND NEW AND ITS FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 12234090 ↗