VERTEBRIS 892409020Recalls & reported problems
Richard Wolf GmbH · PUNCH Ø 5.4MM WL 340MM TL 490mm, with irrigation connection, reusable · 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 04055207046913), received between Jul 12, 2023 and Jul 12, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 12, 2023Loose or Intermittent Connection; Loose or Intermittent Connection
A USER FACILITY HAS INFORMED RICHARD WOLF GMBH AN ISSUE REGARDING A PUNCH Ø 5.4 MM WL 340 MM, PART ID: 892409020, LOT # 4500355424. ACCORDING TO THE RECEIVED INFORMATION, "WHEN THE PRODUCT COMES OUT OF THE BOW, A PIECE REMAINS IN THE NURSE'S HAND. THE TIP COMES OFF. NO RISK TO THE PATIENT." ADDITIONALLY, THIS CASE WAS REPORTED BY THE CUSTOMER TO THE FRENCH NATIONAL AGENCY FOR THE SAFETY OF MEDICINES AND HEALTH PRODUCTS (ANSM).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17309594 ↗
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- 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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