SPEEDTRAP 223749Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20886705027160), received between Oct 17, 2018 and May 7, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Separation Problem” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR (ACL) SURGICAL PROCEDURE THE SPEEDTRAP WHITE 30MM 4PK DEVICE SPEED TRAP GRAFT PREPARATION FAILED UPON DEPLOYMENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 21979840 ↗
• MalfunctionJan 8, 2024Migration; Migration

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON 11/3/23 THE RGDFIX FEM3.3MM ST BR XPIN KIT DEVICE WHILE BEING USED WITH A SPEEDTRAP WHITE 30MM 4PK AND A SPEEDTRAP GRN/WHITE 30MM 4PK DEVICE THE DEVICE PULLED OUT. 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. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464380 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 3 OF 5 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH THAT A PATIENT UNDERWENT AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH MENISCAL REPAIR PROCEDURE OF THE LEFT KNEE ON (B)(6) 2023 USING A SPEEDTRAP CONSTRUCT  WHITE, LONG  MULTI-PACK DEVICE. ACCORDING TO THE REPORT, THE PATIENT HAD A REVISION/REOPERATION PROCEDURE ON (B)(6) 2023 DUE TO AN INFECTION. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 17310562 ↗
• MalfunctionMay 10, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL AND LCL RECONSTRUCTION PROCEDURE, THE SPEEDTRAP CONSTRUCT, GREEN/WHITE AND THE SPEEDTRAP CONSTRUCT, WHITE BROKE WHILE BEING SHUTTLED THROUGH THE TUNNEL. THE SALES REP STATED THAT BOTH SUTURES BROKE ON THE UPPER HALF NEAR THE SPEEDTRAP. A SUTURE PASSER AND A SUTURE CUTTER WERE NOT USED IN THIS PROCEDURE. THE SALES REP STATED THE SURGEON WAS USING PROPER SUTURE MANAGEMENT. THE SURGEON SALVAGED THE REMAINDER OF THE BOTH SUTURES AND USED THEM TO COMPLETE THE CASE. THERE WAS NO PATIENT HARM OR SURGICAL DELAY. THE SUTURES WERE IMPLANTED IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8600600 ↗
• MalfunctionDec 20, 2018Separation Problem; Separation Problem

  IT WAS REPORTED THAT DURING AN ACL REPAIR THE SURGEON TRIED TO USE SPEED TRAP BUT 4 OF THE DEVICES MALFUNCTIONED. THERE ARE NO PATIENT CONSEQUENCES. THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON 12/14/18 FROM SALES REPRESENTATIVE STATING: THE FACILITY NAME AND ADDRESS. THE PRODUCT BEING REPORTED WAS BEING USED DURING AN ACL RECONSTRUCTION. THE FAILURE WITH THE (2) PRODUCT CODE: 223749 - SUTURE PULLED OFF THE PLASTIC PART OF DEVICE BEFORE IT COULD BE FULLY PULLED ONTO THE GRAFT. THE PROCEDURE WAS COMPLETED BY USING THE ARTHREX FIBERLOOP. THERE WERE NO DELAYS OR PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8185784 ↗
• MalfunctionOct 17, 2018Loosening of Implant Not Related to Bone-Ingrowth; Separation Problem; Loosening of Implant Not Related to Bone-Ingrowth; Separation Problem

  ADDITIONAL INFORMATION RECEIVED FROM SALES REPRESENTATIVE ON 17DECEMBER2018: IT WAS REPORTED THE PROCEDURE WAS AN ACL RECONSTRUCTION. THE SUTURES PULLED OFF THE PLASTIC PART OF DEVICE BEFORE IT COULD BE FULLY PULLED ONTO THE GRAFT. USED THE ARTHREX FIBERLOOP TO COMPLETE PROCEDURE. IT WAS CONFIRMED THERE WAS NO SURGICAL DELAY OR INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7975091 ↗