CROSSTRAC 72201811Recalls & reported problems
Smith & Nephew, Inc. · XL EXTRA-LONG DISPOSABLE ARTHROSCOPY NEEDLE, 5 PACKAGE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010609793), received between Apr 4, 2018 and Apr 4, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment Of Device Component” (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.
Most reported problems
Device problems
- Detachment Of Device Component1
- Material Separation1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 4, 2018Detachment Of Device Component; Material Separation
IT WAS REPORTED THAT THE DYNOMITE 2.0 PK WAS OPENED AS REQUESTED BY SURGEON. APPROPRIATE 1.6 DRILL USED. SURGEON OPTED NOT TO TAP, ADVANCED SCREW BY HAND. TWISTED GRAY BIT OF HANDLE COUNTERCLOCKWISE 90 DEGREES TO RELEASE ANCHOR. REPORTED THAT AS SURGEON WITHDREW THE ORANGE HANDLE, THE SUTURE THREADS ATTACHED TO THE ANCHOR JUST FREELY DETACHED AND SEPARATED TOGETHER WITH THE NEEDLES. ANCHOR WAS STILL IN BONE. SURGEON ASKED TO OPEN ANOTHER DYNOMITE ANCHOR. SAME DRILL USED. SAME TECHNIQUE USED. DYNOMITE ANCHOR WAS IMPLANTED SUCCESSFULLY. NO OTHER INCIDENT ENCOUNTERED. SLIGHT DELAY TO SURGERY. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7396114 ↗
Other ACCESSORIES,ARTHROSCOPIC devices
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- NA 228302Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC287 reports
- FIRSTPASS 72290128Smith & Nephew, Inc. · ACCESSORIES,ARTHROSCOPIC232 reports
- NA 251723Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC145 reports
- COBRA 3910900093Stryker Corporation · Accessories, arthroscopic138 reports
- FirstPass 72290129Smith & Nephew, Inc. · Accessories, arthroscopic82 reports
- FirstPass 72290130Smith & Nephew, Inc. · Accessories, arthroscopic80 reports
- MITEK 242025Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC61 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 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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