Arthrex® AR-8150PP-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867042919), received between Sep 21, 2021 and Sep 13, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2024Break; Break

  ON (B)(6) 2024 IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS-06649114 THAT AN AR-8150PP-45 POWERPICK WHEN THE TIP OF THE PRODUCT WAS PRESSED AGAINST THE AFFECTED AREA, THE TIP SHRANK. THIS WAS DISCOVERED DURING THE CASE. THIS CASE WAS COMPLETED BY USING ANOTHER PRODUCT OF SAME PRODUCT NUMBER WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20213294 ↗
• MalfunctionAug 15, 2024Break; Break

  IT WAS REPORTED THAT DRILL TIP AND THE SHAFT BROKE DURING A DEMONSTRATION. IT WAS NOTICED BEFORE THE SURGERY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE DW 18-JUL-2024: FURTHER INFORMATION WAS RECEIVED THAT THE REPORTED EVENT OCCURRED DURING A HIP-ARTHROSCOPY. UPDATE DW 30-JUL-2024: THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER AND ALL BROKEN FRAGMENTS WERE RETRIEVED OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19992616 ↗
• MalfunctionJul 18, 2022Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY THE HANDLES OF THE FOUR DEVICES BROKE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE FROM ANOTHER MANUFACTURER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 30-JUN-2022 IT WAS CONFIRMED THAT THE PLASTIC HANDLE BROKE, WHICH PREVENTED THE WIRE FROM SLIDING OUT. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15040488 ↗
• MalfunctionSep 21, 2021Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A ARTHROSCOPIC PROCEDURE WHILE DRILLING IN THE JOINT DEBRIS WAS PRODUCED. THE SURGEON WAS ABLE TO RETRIEVE EVERYTHING OT OF THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12506256 ↗