Y-KNOT Y-BP28Recalls & reported problems
Conmed Corporation · Y-Knot RC Broaching Punch, 2.8 mm · Class 1
All models of Y-KNOT (14)
Data updated Oct 16, 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 10845854040683), received between Aug 26, 2026 and Aug 26, 2026 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.
InjuryAug 26, 2026Material Fragmentation
The distributor reported on behalf of their customer that the device, Y-BP28, Y-Knot RC Broaching Punch, 2.8 mm, was used during a RCR procedure on (b)(6) 2026 when it was reported, ¿During Surgery, while the punch was being struck with a mallet, the tip of the punch broke off and became embedded in the bone. The complaint device was disposed of by the hospital and is therefore not available for return. The procedure was successfully completed using a replacement device Y-BP28. No adverse impact on the patient was reported.¿. There was no report of medical intervention or hospitalization for the patient. The procedure was completed as planned.This report is being raised due to the reported injury of foreign body left in patient.
Patient problems: Foreign Body In Patient
MAUDE report 50450534 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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