Arthrex® AR-8930-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867049185), received between Mar 22, 2017 and Jul 31, 2026 — classified as 2 injuries, 3 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. 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.

• MalfunctionJul 31, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50101548 ↗
• MalfunctionJan 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 01/09/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA E-MAIL THAT AN AR-8930-12 ARTHREX QUICKFIX¿ SCREW PULLED OUT. THIS OCCURRED ON 12/14/2023. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 18581850 ↗
• MalfunctionAug 24, 2021Output Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY AFTER IMPLANTING THE SCREW THE INSERTER DID NOT BREAK OFF. DUE TO THIS FAILURE THE BONE SHATTERED. THE BONE WAS THEN FIXATED WITH A COMPRESSION SCREW AND KIRSCHNER-WIRE TO TREAT THE PATIENT.

  Patient problems: Bone Shedding Debris

  MAUDE report 12362132 ↗
• InjuryJul 7, 2017Break; Entrapment of Device

  IT WAS REPORTED VIA FDA MEDWATCH (B)(4) WHICH WAS SUBMITTED BY THE FACILITY: "PER THE OPERATIVE REPORT...ANOTHER 2.0 ARTHREX 5 SCREW WAS DETERMINED TO BE PLACED PRODUCING SCLEROSIS. THE SCREW DID BREAK-OFF AND WAS UNABLE TO BE REMOVED DUE TO THE IMPLANTATION OF THE BONE. MULTIPLE ATTEMPTS WERE MADE TO REMOVE AND IT WAS TRIMMED-OFF AS SHORT AS POSSIBLE." (THIS DESCRIPTION IN QUOTES IS EXACTLY AS ENTERED BY THE FACILITY MEDWATCH REPORTER) INTENDED PROCEDURE WAS A LEFT 3RD HAMMERTOE CORRECTION WITH PIP FUSION. UPDATE 6/22/2017: BASED ON THE DEVICE RETURNED AND THE EVENT DESCRIPTION PROVIDED THE MOST LIKELY PART NUMBER WAS DETERMINED TO BE AR-8930-12. FACILITY MEDWATCH REPORTER HAS RETIRED SINCE SUBMITTING MEDWATCH (B)(4). CURRENT RISK MANAGER WAS ABLE TO LOCATE THE REMAINING PIECE OF THE BROKEN SCREW AND IT HAS BEEN RETURNED. CURRENT RISK MANAGER HAS BEEN UNABLE TO OBTAIN OR PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 6692699 ↗
• InjuryMar 22, 2017Break; Difficult to Remove

  IT WAS REPORTED ON 9/15/2016 BY A PATIENT VIA THE ARTHREX WEBSITE THAT THE PATIENT HAD UNDERGONE FOOT SURGERY (B)(6) 2015. SURGERY WAS LEFT PROXIMAL BUNIONECTOMY IN CONJUNCTION WITH 2ND MTP RECONSTRUCTION FOLLOWING DISLOCATION AND PRIOR PODIATRIC MANAGEMENT. DURING THE SURGERY THE FOLLOWING PARTS WERE IMPLANTED: AR13200M-055R ((B)(4)), AR-8724-16 ((B)(4)), AR-8724-12 ((B)(4)), AR-8724-14 ((B)(4)), AR-8724-18 ((B)(4)), AR-8930-12 ((B)(4)) AND AR-8724-12PT ((B)(4)). ON (B)(6) 2016 PATIENT FOLLOWED UP WITH SURGEON DUE TO RECENT ONSET OF LEFT MID-FOOT PAIN AND SWELLING. MEDICAL RECORDS NOTED THAT UPON EXAMINATION OF THE LEFT FOOT THERE WAS PAIN AT THE 1ST TMT AND PROXIMAL OSTEOTOMY SITE WITH VISIBLE SWELLING. THERE WAS NO ERYTHEMA, DRAINAGE OR OTHER EVIDENCE OF INFECTION. X-RAY RESULTS NOTED THERE IS BROKEN HARDWARE (PROXIMAL BUNION PLATE - AR-13200M-055R) WITH QUESTION OF NON-UNION. SURGEON HAS RECOMMENDED A PROXIMAL LEFT BUNION HARDWARE REMOVAL WITH A PLAN TO PROCEED WITH A LAPIDUS FUSION IF IN FACT THE OSTEOTOMY IS INCOMPLETE. PATIENT REVISION IS TENTATIVELY SCHEDULED FOR EARLY 2017 DUE TO PATIENT LACK OF AVAILABLE TIME OFF FROM WORK. ADDITIONAL INFORMATION RECEIVED 2/28/2017: THE R

  Patient problems: Foreign Body In Patient; Pain; Swelling

  MAUDE report 6424850 ↗