RAP-PAC 72202798Recalls & reported problems
Smith & Nephew, Inc. · 1.2 RAP-PAC C LATEX FREE · Class 1
Data updated Oct 16, 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 00885556541296), received between Jan 27, 2020 and Jun 18, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2025Break; Break
IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE 1.2 RAP-PAC C LATEX FREE BROKE OFF INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE WITH NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22288617 ↗MalfunctionJan 27, 2020Material Separation; Material Separation
IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION SURGERY, WHILE DRILLING OVER THE TIBIAL PIN, THE REAMER BROKE THE 2.4 MM TIBIAL PIN IN TWO PIECES. THE SURGEON WAS ABLE TO GET BOTH PIECES OF THE PIN OUT; WHICH WAS CONFIRMED VIA FLUOROSCOPY. THERE WAS A BACK-UP AVAILABLE. IT IS UNKNOWN IF SURGERY WAS DELAYED. THE PATIENT WAS NOT STATED TO BE HARMED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9631647 ↗
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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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