Arthrex® AR-600PD-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867110977), received between Feb 28, 2022 and Aug 22, 2025 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2025Unstable; Unstable

  ON 6TH AUGUST 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT FOR AN AR-600PD-3, PIN DRIVER ATTACHMENT 0.8 - 4.0 MM, AR-600 WIRE DRIVER ATTACHMENT WAS NOT FIRMLY GRIPPED. UPON TEST DRILL, THE WIRE WOBBLED AND SHOOK A LOT WHICH MAY CAUSE INACCURATE TRAJECTORY DURING DRILLING. THIS WAS DETECTED DURING USE IN A KNEE ACL ALL INSIDE PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH HOSPITAL UNIT POWER TOOL.

  Patient problems: Insufficient Information

  MAUDE report 22873233 ↗
• MalfunctionJun 19, 2025Break; Break

  ON 05/28/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT AN AR-600PD-3 PIN DRIVER'S WIRE ATTACHMENT BROKE OFF. DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289469 ↗
• MalfunctionMay 2, 2024Break; Break

  ON 04/09/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06534706 THAT AN AR-600PD-3 PIN DRIVER ATTACHMENT WAS BROKEN THE PIN WAS SPINNING FREELY. THIS OCCURRED DURING A CASE WITH NO EFFECT ON THE PATIENT OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19235119 ↗
• MalfunctionApr 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED ON 3/27/2024: THIS WAS DISCOVERED DURING A TKA PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED USING ANOTHER SET WITH NO DELAY OR ADVERSE EFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19130088 ↗
• MalfunctionFeb 14, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SURGERY THE TWO ATTACHMENTS DO NOT HOLD THE K-WIRES IN PLACE. ALSO THE K-WIRES AND THE ATTACHMENT HEAT UP DURING DRILLING. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE (AR-600DJ). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18705196 ↗
• MalfunctionFeb 14, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SURGERY THE TWO ATTACHMENTS DO NOT HOLD THE K-WIRES IN PLACE. ALSO THE K-WIRES AND THE ATTACHMENT HEAT UP DURING DRILLING. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE (AR-600DJ). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18705125 ↗
• MalfunctionFeb 28, 2022Output Problem

  IT WAS REPORTED THAT DURING A RECON PROCEDURE THE DEVICE PULLED OUT BITS OF THE WIRES. NO PART OF THE DEVICE BROKE OFF. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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. UPDATE 17-FEB-2022: IT WAS CONFIRMED THAT THE GUIDE WIRES WERE TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13621341 ↗