SPEEDTRAP 223748Recalls & reported problems
Medos International Sàrl · SPEEDTRAP Graft Preparation System GREEN/WHITE 30 mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705027156), received between Oct 20, 2020 and Nov 29, 2023 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility2
- Break1
- Delivered as Unsterile Product1
- Mechanical Jam1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 29, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED BY THE SALES REP IN HONG KONG THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE SUTURE OF THE SPEEDTRAP CONSTRUCT GREEN/WHITE, LONG DEVICE FAILED TO DEPLOY COMPLETELY. THE SURGERY WAS COMPLETED SUCCESSFULLY. 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 18229027 ↗MalfunctionFeb 1, 2023Break; Break
IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE SPEEDTRAP CONSTRUCT GREEN/WHITE, LONG DEVICE BROKE WHEN IT WAS PULLED. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16277638 ↗MalfunctionJun 5, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED BY THE SALES REP IN AUSTRALIA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE SPEEDTRAP CONSTRUCT GREEN/WHITE, LONG SUTURE DEVICE WAS STUCK MIDWAY THROUGH DEPLOYMENT THAT IT WOULD NO LONGER PULL THROUGH. THE SUTURE WAS CUT OFF THE TENDON GRAFT; AND ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF TWO MINUTES. THERE WERE FRAGMENTS GENERATED BUT WERE EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14599587 ↗MalfunctionDec 29, 2020Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam
IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE SUTURE STAYED BLOCKED IN THE SPEEDTRAP CAGE WHILE SUTURING THE ANTERIOR LATERAL LIGAMENT. THE SUTURE WAS REMOVED SMOOTHLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIVE MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11089491 ↗MalfunctionOct 20, 2020Delivered as Unsterile Product; Delivered as Unsterile Product
THE EXTREMITY OF THE WIRE WAS ATTACHED TO THE CAP OF THE PACKAGING DURING THE SEALING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10708534 ↗
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE devices
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- Arthrex® AR-4501Arthrex, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE403 reports
- FAST-FIX 72205324Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE383 reports
- LUPINE ORTHOCORD 210712Medos International Sàrl · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE357 reports
- FAST-FIX 72201494Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE249 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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