NA PDL102Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034700205), received between Jul 22, 2019 and Mar 21, 2024 — 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PDL MALLET HAD A TACKY HANDLE. IT WAS NOT REPORTED AS HAVING BEEN USED IN ANY SURGERY OR DAMAGED IN THE FIELD. ALL MALFUNCTIONS WERE NOTED AT INCOMING INSPECTION FROM THE FIELD. THIS REPORT IS FOR ONE (1) SLOTTED MALLET. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18952305 ↗
• MalfunctionJul 22, 2019Break; Component Missing; Device Contamination with Chemical or Other Material; Break; Component Missing; Device Contamination with Chemical or Other Material

  IT WAS REPORTED ON (B)(6) 2019, THE REPAIR TECHNICIAN FOUND THAT THE SLOTTED MALLET POLYETHYLENE CAP WAS BROKEN AND PARTS MISSING. THERE IS STILL ADHESIVE FOUND ON THE PART. THIS WAS DISCOVERED BY THE SERVICE AND REPAIR DEPARTMENT. THERE IS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SLOTTED MALLET. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8813831 ↗