Arthrex® AR-8737-62Recalls & reported problems
Arthrex, Inc. · Easy-out, Mini/Standard Compression FT · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867263833), received between Jan 31, 2022 and Oct 23, 2025 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (7 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.
Reports received per month
Most reported problems
Device problems
- Break7
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 23, 2025Break; Break
IT WAS REPORTED THAT DURING A REMOVAL OF AN ARTHREX PLATE THE TIP OF THE SCREWDRIVER BROKE OFF. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23368414 ↗MalfunctionJun 20, 2025Break; Break
ON 05/29/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8737-62 MINI EASY-OUT SCREW REMOVER TIP BROKE OFF DURING A CASE, AND NO PATIENT WAS HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22296588 ↗MalfunctionAug 21, 2024Break; Break
IT WAS REPORTED THAT DURING A FOOT SURGERY THE TIP BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 20011328 ↗MalfunctionJan 3, 2024Break; Break
IT WAS REPORTED THAT DURING A LAPIDUS SURGERY THE TIP OF THE SCREW REMOVER BROKE WHEN TRYING TO REMOVE A BROKEN SCREW. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME SCREW REMOVER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE 15-DEC-2023: THE BATCH NUMBER FOR THE AR-8737-62 WAS PROVIDED (1391942).
Patient problems: Insufficient Information
MAUDE report 18437325 ↗MalfunctionJan 2, 2024Break; Break
IT WAS REPORTED THAT DURING A LAPIDUS SURGERY THE TIP OF THE DEVICE BROKE WHEN TRYING TO REMOVE A BROKEN SCREW FROM THE PATIENT. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18430178 ↗MalfunctionJan 9, 2023Break
IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8737-62 EASY OUT TOOL BROKE WHILE REMOVING HARDWARE. CASE INVOLVEMENT, DEVICE BROKE DURING USE PER FACILITY: THREADED IN THE TOOL AND THE TIP BROKE INSIDE THE SCREW AND DID NOT CAPTURE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 16120616 ↗MalfunctionJan 31, 2022Break
IT WAS REPORTED THAT DURING A METAL REMOVAL OF TWO SCREWS AR-8730-42HS (LOT 10327710) AND AR-8730-46HS (LOT 10327712) THE HEAD OF THE SCREW AR-8730-46HS (LOT 10327712) BROKE DURING UNSCREWING WITH THE NORMAL SCREWDRIVER FOR THE DEVICE. THE DEVICE AR-8737-62 (LOT 1391931) WAS THEN USED TO GRASP THE BROKEN SCREW AND ALSO BROKE. THE BROKEN SCREW HAD TO BE CHISELED FREE TO REMOVE IT, WHICH CAUSED MUCH DAMAGE TO THE BONE. THE DURATION OF THE SURGERY WAS PROLONGED BY APPROXIMATELY 45 MINUTES DUE TO THE FAILURES. NO BROKEN PARTS REMAINED INSIDE THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY AND IT WAS NOT NECESSARY TO DO A SECOND SURGERY.
Patient problems: Insufficient Information
MAUDE report 13395975 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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