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Arthrex® AR-18700-28Recalls & reported problems

Arthrex, Inc. · PLATE CUTTER · Class 1

Data updated Oct 13, 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 00888867317833), received between Oct 31, 2022 and Apr 15, 2026 — 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 3 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break2
  • Defective Device2
  • Device Dislodged or Dislocated2
  • Detachment of Device or Device Component1

Patient problems

  • No Clinical Signs, Symptoms or Conditions6
  • Insufficient Information1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 15, 2026Break

    IT WAS REPORTED THAT DURING THE PLATE OSTEOSYNTHESIS OF THE METACARPUS, THE PLATE CUTTER BROKE WHILE CUTTING A PLATE. THE BREAK OCCURRED OUTSIDE THE PATIENT¿S BODY. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24884864 ↗
  • MalfunctionJun 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT THE SCREWS ON THE AR-18700-28 HAVE COME LOOSE OVER TIME AND ARE NO LONGER IN THE INSTRUMENT.

    Patient problems: Insufficient Information

    MAUDE report 19531333 ↗
  • MalfunctionJun 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

    ON 11/02/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-18700-28 PLATE CUTTERS SCREWS FELL OUT. THIS OCCURRED IN A CASE WHILE USING THE CUTTER, THE SCREWS JUST FELL OUT. THERE WAS NO PATIENT EFFECT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19494136 ↗
  • MalfunctionJun 5, 2024Defective Device; Defective Device

    IT WAS REPORTED ON 09/22/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-18700-28 PLATE CUTTER AND AR-18720P-12 Y-PLATE ARE MALFUNCTIONING. " PLATE WAS ATTEMPTED TO BE CUT USING MINIFRAG PLATE CUTTER THAT WAS MISSING A SCREW AND IT CUT THE PLATE IMPROPERLY.". THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19471303 ↗
  • MalfunctionMay 21, 2024Defective Device; Defective Device

    IT WAS REPORTED ON 10/18/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-18700-28 PLATE CUTTER IS MALFUNCTIONING NON-SPECIFICALLY. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19358787 ↗
  • MalfunctionJun 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-18700-28 PLATE CUTTERS SILICONE PIECE CAME OUT. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17054446 ↗
  • MalfunctionOct 31, 2022Break

    IT WAS REPORTED ON (B)(6) 2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-18700-28 PLATE CUTTER IS DAMAGED NON-SPECIFICALLY. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO PATIENT HARM. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15698166 ↗

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Sources and updates

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