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
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 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page