Arthrex® AR-8916SPNRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867183674), received between Dec 26, 2019 and Aug 26, 2025 — classified as 4 injuries, 1 malfunction.

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 16, 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.

• InjuryAug 26, 2025Break; Break

  IT WAS REPORTED BY A PATIENT THAT HE HAD A WRIST FUSION ABOUT A YEAR AGO AND THE PLATE BROKE INTO TWO PARTS AFTER 5 WEEKS. A REVISION SURGERY HAS BEEN DONE AND THE PLATE HAS BEEN REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22897862 ↗
• MalfunctionJan 3, 2024Break; Break

  ON 7/12/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8916SPN WRIST SPANNING PLATE BROKE. ADDITIONAL INFORMATION REQUESTED

  Patient problems: Insufficient Information

  MAUDE report 18439881 ↗
• InjuryDec 26, 2019Device Slipped

  IT WAS REPORTED THAT THE SURGEON HAD TO REMOVE THE WRIST SPANNING PLATE, AR-8916SPN, BECAUSE THE SCREWS WERE BACKING OUT OF THE DISTAL HOLES. NO FURTHER INFORMATION, ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 12/18/19: CASE DATE OF IMPLANTATION: (B)(6) 2019, CASE DATE OF EXPLANTATION: (B)(6) 2019. THE FOLLOWING SCREWS WERE ALSO EXPLANTED DURING THE REVISION: AR-8916SPN LOT: 105641930, AR-8724-10 LOT: W646301, AR-8724V-10 LOT: 2610171, AR-8724V-12 LOT: W657601, AR-8935-14 LOT: 10279504, AR-8935L-12 LOT: 10257929, AR-8935L-14 LOT: 10277889.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9519741 ↗
• InjuryDec 26, 2019Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SURGEON HAD TO REMOVE THE WRIST SPANNING PLATE, AR-8916SPN, BECAUSE THE SCREWS WERE NOT LOCKED INTO THE DISTAL HOLES. NO FURTHER INFORMATION, ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 12/18/19: CASE DATE OF IMPLANTATION: 7/11/2019, CASE DATE OF EXPLANTATION: NOT YET DETERMINED. THE FOLLOWING SCREWS WERE ALSO EXPLANTED DURING THE REVISION: AR-8724-10 LOT: 1058931, AR-8724V-10 LOT: W654331, AR-8724V-16 LOT: W630941, AR-8935-12 LOT: 10220124, AR-8935L-12 LOT: 10248943, AR-8935L-12 LOT: 10257929. (DATE OF EXPLANTING PROCEDURE UNKNOWN. (B)(6) 2019 DATE OF REPORT TO ARTHREX HAS BEEN ENTERED AS DATE OF EVENT/EXPLANT.)

  Patient problems: No Code Available

  MAUDE report 9519702 ↗
• InjuryDec 26, 2019Device Slipped

  IT WAS REPORTED THAT THE SURGEON HAD TO REMOVE THE WRIST SPANNING PLATE, AR-8916SPN, BECAUSE THE SCREWS WERE BACKING OUT OF THE DISTAL HOLES. NO FURTHER INFORMATION, ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 12/18/2019: CASE DATE OF IMPLANTATION: (B)(6) 2019, CASE DATE OF EXPLANTATION: (B)(6) 2019. THE FOLLOWING SCREWS WERE ALSO EXPLANTED DURING THE REVISION: AR-8724-12, LOT: 2542021, AR-8724V-12, LOT: 2605841, AR-8724V-18, LOT: 2605831, AR-8935-14, LOT: 10176201, AR-8935-14, LOT:10249431. (DATE OF EXPLANTING PROCEDURE UNKNOWN, (B)(6) 2019 DATE OF REPORT TO ARTHREX HAS BEEN ENTERED AS DATE OF EVENT/ EXPLANT.)

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9519684 ↗