SPEEDTRAP 223750Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20886705027177), received between Jun 19, 2018 and Jan 8, 2024 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 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 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464399 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 2 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  GREEN/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 17310529 ↗
• MalfunctionJun 25, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED BY THE SALES REP VIA CST THAT THE 30MM SPEEDTRAP GREEN/WHITE FIRST SUTURE WAS PULLED BY THE TECH AND PULLED FINE, BUT THE SECOND SUTURE BROKE AS SOON AS IT HAD ANY TENSION ON IT. THE BREAKAGE OCCURRED WHEN PREPPING THE GRAFT ON THE BACK TABLE. THE CASE WAS COMPLETED WITH ANOTHER SPEEDTRAP WITHOUT PATIENT HARM OR DELAY. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE ALLEGED MALFUNCTION OCCURRED DURING AN ACL PROCEDURE AND HE STATED THE SUTURE BROKE IN THE MIDDLE. THE AFFILIATE ALSO REPORTED THAT THE SUTURE WAS NOT IN CONTACT WITH ANY INSTRUMENTS WHILE IN USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8733053 ↗
• MalfunctionJan 30, 2019Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION THE SPEEDTRAP SUTURE FRAYED AND BROKE UPON CYCLING THE KNEE. THERE WAS NO PATIENT CONSEQUENCE AS THE SURGEON WAS ABLE TO GET SCREW FIXATION WITHOUT COMPROMISE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8290128 ↗
• 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 (B)(4) - 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 8185798 ↗
• 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 ON 11/6/2018. THE SALES REP STATED THAT THE QUANTITY OF THE PRODUCTS INVOLVED IS 4 BUT IT LOOKS LIKE TWO BECAUSE THEY COME IN PACKS OF FOUR. TWO OF EACH PRODUCT CODE FAILED. THE DEVICE STATUS IS DISCARDED. IT WAS REPORTED THAT THE ISSUE WAS DETECTED IMMEDIATELY. THE BONE WAS NOT DAMAGED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT COMPANY'S PRODUCT WITH NO SURGICAL DELAY. THE DEVICE WAS NOT REMOVED/REPLACED IN ANOTHER PROCEDURE. THERE WAS NO SURGICAL INTERVENTION PLANNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7975081 ↗
• MalfunctionJun 19, 2018Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHILE PULLING THE SUTURE IN LINE WITH GRAFT, SUTURE SHREDDED AND BROKE. IT SEEMED LIKE THE SUTURE WAS WAS PARTIALLY PINCHED IN THE PLASTIC HOLDER. WE TRIED A COUPLE OFF DIFFERENT DEVICES AND THE SAME THING HAPPENED. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDTRAP DEVICE FROM A DIFFERENT LOT AND IT WORKED FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7616248 ↗
• MalfunctionJun 19, 2018Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHILE PULLING THE SUTURE IN LINE WITH GRAFT, SUTURE SHREDDED AND BROKE. IT SEEMED LIKE THE SUTURE WAS PARTIALLY PINCHED IN THE PLASTIC HOLDER. WE TRIED A COUPLE OFF DIFFERENT DEVICES AND THE SAME THING HAPPENED. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDTRAP DEVICE FROM A DIFFERENT LOT AND IT WORKED FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7616133 ↗
• MalfunctionJun 19, 2018Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHILE PULLING THE SUTURE IN LINE WITH GRAFT, SUTURE SHREDDED AND BROKE. IT SEEMED LIKE THE SUTURE WAS PARTIALLY PINCHED IN THE PLASTIC HOLDER. WE TRIED A COUPLE OFF DIFFERENT DEVICES AND THE SAME THING HAPPENED. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDTRAP DEVICE FROM A DIFFERENT LOT AND IT WORKED FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7616113 ↗