SPEEDTRAP 223747Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886705027149), received between Jun 4, 2018 and Jan 14, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE BEFORE TIGHTENING THE SPEEDTRAP WHITE 30MM DEVICE THE SUTURE DETACHED BEFORE TIGHTENING. THE PROCEDURE WAS COMPLETE SUCCESSFULLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. NO FRAGMENTS WERE GENERATED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2024. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21152088 ↗
• MalfunctionJan 10, 2025Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE, THE SPEEDTRAP WHITE 30MM DEVICE COULD NOT BE PULLED OUT AND ATTACHED TO THE GRAFT AFTER A FEW TRIES BY THE SURGEON. 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 21123433 ↗
• MalfunctionMay 22, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE SPEEDTRAP WHITE 30MM SUTURE LOOSENED PRIOR TO USE. ANOTHER LIKE 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 19369239 ↗
• MalfunctionJan 18, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE SPEEDTRAP CONSTRUCT WHITE, 30MM DEVICE SUTURE WAS BROKEN OFF. 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 18533692 ↗
• MalfunctionApr 18, 2023Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  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  WHITE, LONG DEVICE WAS DAMAGED AT THE END OF THE GRAFT THAT CAUSED THE GRAFT TO BREAK. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE WINDING WHITE SUTURE ON THE DEVICE WAS FRAYED AND BROKEN. 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 16763312 ↗
• MalfunctionSep 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP IN HONG KONG THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION) PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE SPEEDTRAP CONSTRUCT  WHITE, LONG DEVICE FAILED TO COMPRESS ONTO THE GRAFT; AND THEREFORE, FELL OFF FROM 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 15495024 ↗
• 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 12033720 ↗
• MalfunctionJan 22, 2020Positioning Failure; Positioning Failure

  IT WAS REPORTED BY THE AFFILIATE THAT DURING AN UNKNOWN PROCEDURE THE SPEEDTRAP WHITE 30MM FAILED TO DEPLOY. ADDITIONAL INFORMATION COULD NOT BE PROVIDED REGARDING THE EVENT OUTCOME, PATIENT STATUS, OR IF THE DEVICE WILL BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9619427 ↗
• MalfunctionJun 4, 2018Migration or Expulsion of Device; Loosening of Implant Not Related to Bone-Ingrowth; Migration or Expulsion of Device; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED BY OUR AFFILIATE THAT THE REPORTED PRODUCT WAS USED FOR THE ACL RECONSTRUCTION BY TENSIONING TO THE SEMITENDINOSUS MUSCLE ON (B)(6) 2018. IT WAS REPORTED THAT THE SUTURE WAS DETACHED WHEN THE ADJUSTABLE SUTURE WAS INSERTED TO THE BONE HOLE. THE ADJUSTABLE SUTURE COULD NOT APPLY ENOUGH TENSION TO THE SEMITENDINOSUS MUSCLE. THE SURGERY WAS COMPLETED BY INSERTING THE ANCHOR TO OPPOSITE SIDE OF THE GRAFT. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS LESS THAN 30 MIN. SURGICAL DELAY AND NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7566941 ↗