NA LINC9248Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888551000192), received between Sep 21, 2018 and Nov 9, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 9, 2018Break; Break

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD MALE PATIENT, UNDERWENT A RIGHT KNEE ARTHROSCOPY PROCEDURE WITH A SHAVER BLADE FULL-RADIUS RESECTOR LARGE HUB YELLOW AND SECOND-DEGREE BURN OCCURRED. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM FOR A KNEE SCOPE ON THE RIGHT KNEE. PROCEDURE WAS GOING AS PLANNED WITH NO ISSUES AND SURGEON WAS USING A FULL RADIUS RESECTOR WHEN BOTH THE SURGICAL TECHNICIAN AND THE PHYSICIAN ASSISTANT (PA) NOTICED A BURNING SMELL. SCRUB LOOKED DOWN AND SAW SOME SMOKE COMING FROM THE RESECTOR AND IMMEDIATELY NOTICED THAT IT WAS BROKEN, NO FIRE WAS NOTICED. SHE NOTIFIED THE SURGEON, WHO STOPPED WHAT HE WAS DOING AND REMOVED THE INSTRUMENT. THE RESECTOR WAS INSPECTED AND FOUND TO BE OBVIOUSLY BROKEN. SURGEON AND PA STARTED TO INSPECT THE KNEE AT THE PORTAL SITE AND NOTED THAT THERE WAS SOME POSSIBLE TEARING. IT WAS LATER DETERMINED THAT IT WAS MOST LIKELY A SECOND DEGREE BURN AT THE INCISION SITE WHERE THE SHAVER WAS BEING USED IN THE KNEE. THE SPOT WAS MEASURED, AND PICTURES WERE TAKEN. A NEW DEVICE, 3.5 FILL RADIUS SHAVER WAS OPENED, AND THE CASE CONTINUED AND COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. THE PHYSICIAN¿S OPINION ON THE ORIGIN OF THE SMOKE IT WA

  Patient problems: Burn(s)

  MAUDE report 8055812 ↗
• MalfunctionSep 21, 2018Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE ARTHROSCOPY PROCEDURE WITH A ¿SHAVER BLADE FULL-RADIUS RESECTOR LARGE HUB YELLOW¿. THE SHAVER BLADE LEFT METAL SHAVINGS IN THE PATIENT DURING SURGERY. THE PHYSICIAN WAS ABLE TO RUB THEM OUT OF THE PATIENT. THE SHAVER BLADE WAS ALSO MAKING A CLICKING SOUND DURING USE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE CLICKING SOUND WAS ASSESSED AS NOT REPORTABLE. THE METAL SHAVINGS LEFT IN THE PATIENT WAS ASSESSED AS A REPORTABLE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7900193 ↗
• MalfunctionSep 21, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTHROSCOPIC KNEE PROCEDURE WITH A SHAVER BLADE FULL-RADIUS RESECTOR LARGE HUB YELLOW AND THE SHAVER BROKE INTO TWO PIECES WITH NO FRAGMENTS WHILE IN USE INSIDE OF THE PATIENT. AN ALTERNATE DEVICE WAS USED TO FINISH THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS EVENT HAS BEEN ASSESSED AS A REPORTABLE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7900191 ↗