Progressive proximal rasp PIP 211-A43000Recalls & reported problems
Keri Medical SA · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07640181161560), received between Feb 27, 2026 and Jul 17, 2026 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break4
Patient problems
- Device Embedded In Tissue or Plaque4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2026Break
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 25856586 ↗InjuryApr 1, 2026Break
IT WAS REPORTED THAT DURING THE PROCEDURE, THE RASP BROKE OFF AND THE BROKEN PART WAS STUCK IN THE BONE AND THIS WAS DIFFICULT TO REMOVE. THE TIME OF THE SURGERY HAS BEEN EXTENDED BY 45 MINUTES. THIS EVENT INVOLVED UNPLANNED SURGICAL INTERVENTION TO REMOVE THE FRAGMENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24759841 ↗InjuryMar 6, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE RASP FRACTURED AND REMAINED INSIDE THE PATIENT. THE SURGEON USED A CONICAL BURR AND A FINE K-WIRE TO RETRIEVE THE RETAINED METAL FRAGMENT. THE EVENT RESULTED IN AN ADDITIONAL SURGICAL TIME OF APPROXIMATELY 30 MINUTES, AND THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24532185 ↗InjuryFeb 27, 2026Break
IT WAS REPORTED THAT DURING THE PROCEDURE, THE RASP BROKE OFF AND THE BROKEN PART WAS STUCK IN THE BONE AND THIS WAS DIFFICULT TO REMOVE. THE TIME OF THE SURGERY HAS BEEN EXTENDED BY 45 MINUTES. THIS EVENT INVOLVED UNPLANNED SURGICAL INTERVENTION TO REMOVE THE FRAGMENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24470902 ↗
Other Rasp, Surgical, General & Plastic Surgery devices
- VG2 273340107Medos International Sàrl · RASP, SURGICAL, GENERAL & PLASTIC SURGERY2 reports
- VG2 273340106Medos International Sàrl · RASP, SURGICAL, GENERAL & PLASTIC SURGERY2 reports
- VG2 273340108Medos International Sàrl · RASP, SURGICAL, GENERAL & PLASTIC SURGERY1 report
- NA 698273327Depuy Spine, LLC · RASP, SURGICAL, GENERAL & PLASTIC SURGERY1 report
- Innomed, Inc. 3004-01Innomed, Inc. · Rasp, Surgical, General & Plastic Surgery1 report
- CONCORDE 287903001Depuy Spine, LLC · RASP, SURGICAL, GENERAL & PLASTIC SURGERY1 report
- CONCORDE 287903003Depuy Spine, LLC · RASP, SURGICAL, GENERAL & PLASTIC SURGERY1 report
- VG2 273340110Medos International Sàrl · RASP, SURGICAL, GENERAL & PLASTIC SURGERY1 report
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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