Arthrex® AR-9401-17Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888867060333), received between May 22, 2017 and Sep 8, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2025Break; Break

  IT WAS REPORTED THAT DURING A REVISION SURGERY OF A SHOULDER PROSTHESIS; IT WAS NOT POSSIBLE TO USE THE AR-9401-17 IN THE NOTCHES AS USUAL. INSTEAD, THE IMPLANT HAD TO BE BROKEN UP AND THE EXTRACTION INSTRUMENT BROKE. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. IN ADDITION, AR-9545-T15-02 WAS WORN OUT ON ARRIVAL. THE DEVICE COULD BE USED DURING SURGERY BUT SHOULD NOT BE USED AGAIN. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICES. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 22998588 ↗
• MalfunctionNov 20, 2024Break; Break

  ON 10/29/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9401-17 ARTHREX ECLIPSE¿ DURING A CASE THE HUMERAL HEAD EXTRACTOR BROKE WHILE TRYING TO MALLET IT INTO THE REVISION BUT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 20733570 ↗
• MalfunctionNov 7, 2024Break; Break

  ON 10/21/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9401-17 ARTHREX ECLIPSE¿ HUMERAL HEAD EXTRACTOR BROKE OFF. THIS OCCURRED DURING AN ECLIPSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE THE HEAD EXTRACTOR BROKE OFF WHEN REMOVING THE TRIAL HEAD AND THE FRAGMENT WAS RETRIEVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20630084 ↗
• MalfunctionJun 5, 2024Break; Break

  ON 6/17/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9401-17 EXTRACTOR IS BROKEN. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19472605 ↗
• MalfunctionMay 25, 2024Break; Break

  ON 11/18/2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT A AR-9401-17 EXTRACTOR BROKE. THIS OCCURRED DURING A CASE, AND THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19398212 ↗
• MalfunctionMay 15, 2024Break; Break

  ON (B)(6) 2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT A AR-9401-17 ECLIPSE IS BROKEN. THIS WAS DISCOVERED IN A CASE. THERE WAS NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19319432 ↗
• MalfunctionOct 31, 2022Break

  ON (B)(6)2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-9401-17 HUMERAL HEAD EXTRACTOR CHIPPED. THIS OCCURRED DURING AN ECLIPSE PROCEDURE WHILE REMOVING THE HUMERAL HEAD THE END OF IT CHIPPED. THE COMPONENT WAS REMOVED USING A STANDARD OSTEOTOME, AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15698293 ↗
• MalfunctionJun 20, 2022Break

  ON 06/03/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9401-17 ECLIPSE¿ HUMERAL HEAD EXTRACTOR BROKE IN AN UNSPECIFIED PROCEDURE. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 06/20/2022, THE SALES REPRESENTATIVE STATED THE FOLLOWING INFORMATION VIA EMAIL: THIS EVENT OCCURRED DURING A TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2022, NO ATTACHMENT WAS USED WITH THE DEVICE. A PIECE BROKE INSIDE THE PATIENT, AND THE PIECE WAS RETRIEVED. AN OSTEOTOME HAD TO BE USED AS A REPLACEMENT, THE CASE WAS COMPLETED SUCCESSFULLY AND THE PATIENT IS FINE TO DATE. THE COMPLAINT DEVICE WAS RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14744658 ↗
• MalfunctionMar 12, 2021Break

  IT WAS REPORTED THAT THE AR-9401-17 HUMERAL HEAD EXTRACTOR IS DAMAGED. ADDITIONAL INFORMATION RECEIVED ON 1/27/2021: THE REP REPORTED DAMAGE TO THE DEVICE DID NOT HAPPEN DURING A CASE. THE ISSUE WAS NOTICED BY A STERILE PROCESSING TECH DURING INSPECTION PRIOR TO A CASE. THIS IS NOW REPORTABLE. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED. COMPLAINT CONFIRMED, THE TIP OF THE DEVICE WAS FOUND TO BE DAMAGED. A FRAGMENT BROKE OFF AND WAS NOT RETURNED. THE CAUSE OF THE EVENT IS UNDETERMINED, HOWEVER THE LIKELIEST CAUSE OF THE OBSERVED FAILURE MODE IS USER-APPLIED MECHANICAL FORCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11475109 ↗
• MalfunctionMar 12, 2021Break

  IT WAS REPORTED THAT THE AR-9401-17 HUMERAL HEAD EXTRACTOR IS DAMAGED. ADDITIONAL INFORMATION RECEIVED ON 1/27/2021: THE REP REPORTED DAMAGE TO THE DEVICE DID NOT HAPPEN DURING A CASE. THE ISSUE WAS NOTICED BY A STERILE PROCESSING TECH DURING INSPECTION PRIOR TO A CASE. THIS IS NOW REPORTABLE. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED. COMPLAINT CONFIRMED, THE TIP OF THE DEVICE WAS FOUND TO BE DAMAGED. A FRAGMENT BROKE OFF AND WAS NOT RETURNED. THE CAUSE OF THE EVENT IS UNDETERMINED, HOWEVER THE LIKELIEST CAUSE OF THE OBSERVED FAILURE MODE IS USER-APPLIED MECHANICAL FORCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11475095 ↗
• InjuryMay 22, 2017Break; Difficult to Remove

  IT WAS REPORTED THAT WHILE TRYING TO REMOVE THE IMPLANT AND WORKING WITH IT UNDERNEATH, THE TIP OF THE ECLIPSE HUMERAL HEAD EXTRACTOR BROKE-OFF IN THE PATIENT. SURGEON WAS NOT ABLE TO RETRIEVE THE BROKEN TIP. THE CASE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION RECEIVED 5/11/17: PROCEDURE WAS AN APEX PRIMARY TSA. SURGEON WAS TRYING TO ROTATE THE OFFSET ON THE HUMERAL HEAD IMPLANT. SURGEON FELT IT WAS OFF BY ABOUT 10 DEGREES AND WAS TRYING TO ADJUST IT. A SMALL FRAGMENT OF METAL, THE BROKEN-OFF TIP OF THE DEVICE, WAS LEFT IN THE PATIENT ENGAGED IN THE MORSE TAPE OF THE TRUNNION AND HUMERAL HEAD IMPLANTS. THE FRAGMENT WAS REPORTED TO BE CONTAINED AND NOT FLOATING IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6581008 ↗