Medline Industries, Inc. PHS393024007ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10889942689866), received between Apr 26, 2019 and Jun 21, 2019 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionJun 21, 2019Break; Material Fragmentation; Detachment of Device or Device Component

  ON THREE SEPARATE OCCASIONS, 11 BLADES INCLUDED IN ARTHROSCOPY PACKS HAVE BECOME DETACHED FROM THE HANDLE DURING USE, AND IN SOME CASES THE 11 BLADE HAS BROKEN INTO MULTIPLE PIECES. EVENT 1: PATIENT HAD LEFT SHOULDER ARTHROSCOPY, LABRAL REPAIR WITH CAPSULORRHAPHY, CYST DECOMPRESSION. THEY WERE DISCHARGED HOME THE SAME DAY. PATIENT PRESENTED TO THE ER TWO DAYS LATER FOR SYNCOPE EPISODE. FAMILY MEMBER WAS CHANGING SHOULDER DRESSING AND PATIENT BECAME DIAPHORETIC AND PASSED OUT AND WAS BROUGHT TO ER. PATIENT HAVING SHOULDER PAIN POST OP BUT OTHER THAN THIS FEELING WELL. CARDIAC WORKUP AND LAB RESULTS NORMAL. PATIENT DISCHARGED HOME AND TOLD TO FOLLOW-UP WITH PCP IN TWO DAYS. PATIENT WENT TO SEE HIS SURGEON AND SURGEON GOT AN X-RAY OF THE PATIENT'S SHOULDER. ON X-RAY, AN 11 BLADE WAS FOUND. PATIENT TAKEN TO OUTSIDE FACILITY TO HAVE 11 BLADE REMOVED. EVENT 2: SURGICAL BLADE USED FOR INCISION CAME OFF OF KNIFE HANDLE INSIDE OF KNEE CAVITY DURING KNEE SCOPE PROCEDURE. WHILE RETRIEVING BLADE, THE BLADE BROKE INTO 4 PIECES. 2 LARGE PIECES IMMEDIATELY RETRIEVED AND 3RD PIECE RETRIEVED WITH AID OF C-ARM. BLADE WAS REASSEMBLED AND WE DISCOVERED THAT THE VERY TIP 2MM OF BLADE WAS STILL MISSING.

  Patient problems: Diaphoresis; Foreign Body In Patient; Pain; Syncope

  MAUDE report 8721652 ↗
• InjuryApr 26, 2019Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE POST-OPERATIVE X-RAY REVEALED THAT THE #11 BLADE (FROM THE CUSTOM SURGICAL TRAY) WAS RETAINED IN PATIENT'S LEFT SHOULDER.

  Patient problems: Foreign Body In Patient

  MAUDE report 8557895 ↗
• MalfunctionApr 26, 2019Break

  IT WAS REPORTED THAT WHILE SURGEON WAS MAKING A SKIN INCISION DURING A SHOULDER ARTHROSCOPY, THE #11 SURGICAL BLADE (TAKEN FROM CUSTOM ORTHOPEDIC PACK) BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8557667 ↗