VERTEBRIS 892402225Recalls & reported problems
Richard Wolf GmbH · PUNCH Ø 2.6MM WL 290MM color code orange, TL 388 mm, with irrigation connection, reusable · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04055207035559), received between Feb 25, 2021 and Mar 8, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (2 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.
Most reported problems
Device problems
- Material Integrity Problem2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 8, 2021Material Integrity Problem; Material Integrity Problem
DURING ENDOSCOPIC SPINE SURGERY AT L4-L5 (INTERLAMINAR APPROACH) DISTAL PART OF INSTRUMENT HAS FELL OUT TO SPINAL CANAL - CONVERSION SURGERY TO MINI OPEN WAS NECESSARY. SURGERY WAS PERFOMED BY CERTIFIED SPINE SURGEON BY RIWOSPINE. PROBABLY DISTAL PART OF INSTRUMENT HAS FELL OUT WHEN SURGEON WAS CUTTING ANULUS. CLIENT USE MENTIONED INSTRUMENT ONLY FOR APPROX. 5 SURGERIES BEFORE INCIDENT. (B)(4) HAS CHECKED ALL PROCEDURES WHICH ARE APPLIED IN HOSPITAL (REPROCESING, CLEANING ETC.) AND ALL RW USER MANUALS GUDLINES ARE PROPERLY APPLY BY CLIENT. FOREIGN PART OF RW INSTRUMENT LEFT INSIDE PATIENT BODY.
Patient problems: Insufficient Information
MAUDE report 11436691 ↗MalfunctionFeb 25, 2021Material Integrity Problem; Material Integrity Problem
DURING ENDOSCOPIC SPINE SURGERY AT L5-S1 (INTERLAMINAR APPROACH) DISTAL PART OF INSTRUMENT HAS FEIL OUT TO SPINAL CANAL CONVERSION SURGERY TO MINI OPEN WAS NECESSARY. SURGERY WAS PERFORMED BY CERTIFIED SPINE SURGEON BY (B)(6). PROBABLY DISTAL PART OF INSTRUMENT HAS FEIL OUT WHEN SURGEON WAS CUTTING ANULUS. CLIENT USE MENTIONED INSTRUMENT ONLY FOR APPROX. 3 SURGERIES BEFORE INCIDENT. (B)(6) HAS CHECKED ALL PROCEDURES WHICH ARE APPLIED IN HOSPITAL (REPROCESSING, CLEANING ETC.) AND ALL RW USER MANUALS GUIDELINES ARE PROPERLY APPLY BY CLIENT. CLIENT DEMAND REPLACEMENT FOR NEW INSTRUMENT UNDER WARRANTY. PATIENT IS UNDER CONSTANT CONTROL AT OUTPATIENT CLINIC. SURGERY CONVERSION TO MINI OPEN IN CONJUNCTION WITH TRYING TO FIND FOREIGN BODY OF RICHARD WOLF INSTRUMENT AND END OF SURGERY. TIME OF DELAY SURGERY WAS APPROX. 3 HOURS. FOREIGN PART OF RW INSTRUMENT LEFT INSIDE PATIENT BODY.
Patient problems: Insufficient Information
MAUDE report 11382160 ↗
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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 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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