Spectrum MVP C6400Recalls & reported problems
Conmed Corporation · Spectrum MVP Suture Passer, Disposable, Crescent, Medium · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854019894), received between Dec 16, 2024 and Dec 16, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Material Fragmentation” (1 report).
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
- Material Fragmentation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 16, 2024Material Fragmentation; Material Fragmentation
A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE C6400, SPECTRUM MVP SUTURE PASSER, DISPOSABLE, CRESCENT, MEDIUM DEVICE WAS USED ON 21NOV24, AND ¿DURING A LABRAL REPAIR, A VERY TINY PIECE OF THE "FORK" THAT PASSES THE SUTURE THROUGH THE MVP BROKE OFF WHICH WE ASSUME BROKE INSIDE THE PATIENT. SURGEON DID NOT NOTICE IT BROKE UNTIL WE WENT TO RELOAD ANOTHER SUTURE. THE SMALL PIECE WAS NOT RECOVERED BUT TO OUR KNOWLEDGE NO HARM HAS BEEN DONE TO THE PATIENT. THE PIECE WAS MUCH TOO SMALL FOR FLUOROSCOPY SO WE DID NOT ATTEMPT TO FIND IT IN THE PATIENT.¿. FOLLOW-UP ASSESSMENT FOUND THAT "NO X-RAY OR ULTRASOUND WAS ATTEMPTED, SURGEON FELT THAT THE PIECE WAS WAY TO SMALL TO FIND AND FELT THE SCOPE WOULD SUCK IT UP WITH SUCTION. THE PIECE WAS EXTREMELY EXTREMELY SMALL, THE SURGEON BELIEVES IT BROKE OFF INSIDE THE PATIENT BUT SINCE IT WAS SO SMALL HE FEELS THERE IS A VERY GOOD CHANCE THAT THE SALINE THAT IS PUMPED IN DURING ARTHROSCOPY¿S JUST NATURALLY SUCKED THE FRAGMENT UP INTO THE NEPTUNE AND IS HOPING IT WAS REMOVED FROM THE PATIENTS BODY THAT WAY". THE FRAGMENT WAS SEARCHED FOR OUTSIDE OF THE PATIENT BUT NOT FOUND. THE SURGERY WAS COMPLETED AS NORMAL, WITH THE USE OF "ANOT
Patient problems: Foreign Body In Patient
MAUDE report 20937813 ↗
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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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