DYNACORD 222069Recalls & reported problems
Medos International Sàrl · DYNACORD Suture 1 Blue and 1 White/Blue/Green Striped Braided Composite Suture Number 2 (5 metric), 36 inches (91 cm) · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20886705030030), received between Aug 31, 2023 and Jun 8, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Appropriate Device Problem Term/Code Not Available1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Tissue Injury1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2026Break; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A POST MARKET COMPLICATION OCCURRED DUE TO INTRA OP DEVICE BREAKAGE OF A DYNACORD MULTIPAK W/O NDL DEVICE DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION SURGERY. THE DEVICE HAD BEEN USED WITH THE FMS VUE II SYSTEM AND THE VAPR SYSTEM. THE DEVICE WAS REMOVED AND REPLACED INTRA OPERATIVELY. NO ADDITIONAL IMPACT TO THE PATIENT OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25433811 ↗MalfunctionJul 2, 2024Break; Material Deformation; Break; Material Deformation
THIS IS REPORT 1 OF 5 FOR PC-(B)(4).. IT WAS REPORTED THROUGH CLINICAL RESEARCH THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS OBSERVED THAT THE DYNACORD MULTIPAK W/O NDL DEVICE WAS DEFORMED, WARPED AND DISTORTED THAT LED TO DEVICE BREAKAGE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19657489 ↗InjuryAug 31, 2023Break; Break
THIS IS REPORT 5 OF 5 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH THAT A PATIENT UNDERWENT AN ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE OF THE RIGHT KNEE ON (B)(6) 2023 TREATING AN ACL TEAR. ACCORDING TO THE REPOT, A DYNACORD¿ SUTURES (BLUE, WHITE/BLUE/GREEN), NO NEEDLES. MULTI (12) PACK. DEVICE WAS USED THAT BROKE POSTOPERATIVELY. IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A RE-OPERATION/REVISION PROCEDURE FOR LOOSE BODY REMOVAL. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Unspecified Tissue Injury
MAUDE report 17662388 ↗
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE devices
- FAST-FIX 72202468Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 death6,626 reports
- FAST-FIX 72201491Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE863 reports
- FAST-FIX 72202469Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE561 reports
- FAST-FIX 72205676Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE439 reports
- 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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