Medline ReNewal HAREP103635Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888277379855), received between Nov 1, 2016 and Jun 2, 2017 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2017Material Fragmentation; Material Fragmentation

  WE RECEIVED A REPORT INDICATING THAT THE TIP OF A REPROCESSED ARTHROSCOPIC SHAVER DETACHED DURING USE. THE PHYSICIAN WAS ABLE TO LOCATE AND REMOVE THE DETACHED TIP WITH A GRASPER. A NEW DEVICE AND A BAG OF FLUID WERE NEEDED TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6607354 ↗
• InjuryFeb 3, 2017Material Fragmentation; Material Fragmentation

  WE RECEIVED A REPORT INDICATING THAT A PIECE OF A REPROCESSED ARTHROSCOPIC SHAVER DISLODGED AND FELL INTO THE PATIENT DURING USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6301703 ↗
• MalfunctionNov 8, 2016Material Fragmentation; Material Fragmentation

  MEDLINE RENEWAL RECEIVED A REPORT INDICATING THAT THE TIP OF THE REPROCESSED STRYKER FORMULA AGGRESSIVE PLUS CUTTER, MODEL 375-544-000, BROKE OFF IN THE PATIENT'S SHOULDER DURING USE. THE TIP WAS RETRIEVED BY THE SURGEON, AND DID NOT RESULT IN PATIENT HARM. ANOTHER DEVICE WAS READILY AVAILABLE TO COMPLETE THE PROCEDURE; THEREFORE NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THE INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6088246 ↗
• MalfunctionNov 8, 2016Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDLINE RENEWAL RECEIVED A REPORT INDICATING A REPROCESSED DEPUY MITEK VAPR SIDE EFFECT ELECTRODE, W/INTEGRATED HAND PIECE, MODEL 227301, WAS NOT RECOGNIZED BY THE GENERATOR WHEN IT WAS PLUGGED IN DURING A SURGICAL PROCEDURE. THEREFORE THE DEVICE COULD NOT BE USED. THE REPORT DID NOT INDICATE THAT THE DEVICE FAILURE RESULTED IN ANY PATIENT HARM. ANOTHER DEVICE WAS READILY AVAILABLE TO COMPLETE THE PROCEDURE; THEREFORE NO PATIENT HARM OR ADDITIONAL MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THE INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6088216 ↗
• MalfunctionNov 1, 2016Material Fragmentation; Material Fragmentation

  MEDLINE RENEWAL RECEIVED A REPORT INDICATING THAT THE TIP OF A REPROCESSED STRYKER FORMULA AGGRESSIVE PLUS CUTTER, MODEL 375-544-000, BROKE OFF IN THE PATIENT'S SHOULDER DURING USE. THE REPORT DID NOT INDICATE THAT THE DEVICE FAILURE RESULTED IN PATIENT HARM. ANOTHER DEVICE WAS READILY AVAILABLE TO COMPLETE THE PROCEDURE; THEREFORE NO PATIENT HARM OR ADDITIONAL MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THE INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6071501 ↗