Arthrex® AR-2670Recalls & reported problems
Arthrex, Inc. · 2.7MM SCREW DEPTH INDICATOR · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867098534), received between Oct 3, 2023 and Feb 25, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (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
- Incorrect Measurement2
- Break1
- Defective Device1
- Fitting Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
- Failure of Implant1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 25, 2026Incorrect Measurement
ON 9TH FEBRUARY 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-8943-15, DEPTH DEVICE, 2.7 / 3.5 / 4.0 MM, LOW PROFILE AND AN AR-2670, 2.7MM SCREW DEPTH INDICATOR, THESE 2 DEPTH GAUGES IN THE CLAVICLE FRACTURE TRAY WERE INACCURATE. THIS CAUSED INACCURACIES IN SCREW LENGTH MEASURED. THIS WAS DETECTED DURING A CLAVICLE FRACTURE PROCEDURE ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THEY HAD TO USE X-RAY TO GUESS THE APPROPRIATE SCREW LENGTH. 4 SCREWS WERE WASTED DUE TO WRONG MEASUREMENT, AND THE SCREWS WERE TOO LONG. 10TH FEBRUARY 2026 - THE 4 SCREWS USED WERE AR-8835-20 X 2, AR-8835-24 X 1 AND AR- 8835L-20 X 1. THEY REPLACED THE 4 SCREWS THAT WERE TOO LONG IN THE PRIMARY SURGERY. AS BOTH THE DEPTH DEVICES WERE UNABLE TO PROVIDE PROPER MEASUREMENT, THEY HAD TO REREVISE BY PUTTING SHORTER SCREWS AND PERFORMING AN X-RAY CHECK WHICH CAUSED THE SURGERY TO TAKE LONGER THAN IT WAS SUPPOSED TO. THE COMPLAINT INITIATOR THINKS IT TOOK LONGER THAN 15 MINUTES BECAUSE THE NURSE WENT OUT TO SEARCH FOR POSSIBLE PEEL DEPTH GAUGE AND CAME BACK WITH NO LUCK. THE SURGEON TRIED MANY TIMES TO GET THE CORRECT LENGTH AS WELL. THEY USED X-RAY MULTIPLE TIMES AT DIFFERENT
Patient problems: Insufficient Information
MAUDE report 24441881 ↗MalfunctionJun 18, 2024Break; Break
IT WAS REPORTED ON 01/19/2023 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-2670 SCREW DEPTH INDICATOR BROKE. CASE INVOLVEMENT, NO PATIENT EFFECT..
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19560581 ↗MalfunctionJun 10, 2024Incorrect Measurement; Incorrect Measurement
ON 3/27/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2670 SCREW DEPTH INDICATOR WOULD NOT READ ACCURATELY IN THE DRILL TUNNEL. AS A RESULT, AN AR-8827L-24 LOW PROFILE LOCKING SCREW AND AN AR-8827L-20 LOW PROFILE LOCKING SCREW WERE WASTED. THIS WAS DISCOVERED DURING A DISTAL CLAVICLE PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED WITH A PRODUCT FROM ANOTHER MANUFACTURER.
Patient problems: Insufficient Information
MAUDE report 19498403 ↗MalfunctionDec 4, 2023Defective Device; Defective Device
ON 11/6/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS (B)(4) THAT AN AR-2670 SCREW DEPTH INDICATOR (THE DEVICE IS A LOANER) AND AN AR-8943-15 DEPTH DEVICE (THE DEVICE IS A LOANER) WAS NOT MEASURING CORRECTLY DUE TO THE TWO TIPS BEING SWAPPED THAT WAS CONFIRMED BY THEIR INSPECTION TEAM. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18257700 ↗MalfunctionOct 3, 2023Fitting Problem; Fitting Problem
IT WAS REPORTED THAT THE LENGTH MEASUREMENT DID NOT WORK PROPERLY AND THEREFORE WRONG SCREWS WERE CHOSEN. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. ***UPDATE 13-SEP-2023 NROE: FURTHER INFORMATION REVEALED THAT THIS INCIDENT OCCURRED DURING A CLAVICLE FRACTURE TREATMENT WITH A DISTAL CLAVICLE PLATE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY AFTER REPLACING THE SCREWS THAT WERE TO LONG WITH SHORTER SCREWS. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 17864205 ↗
Other GAUGE, DEPTH devices
- NA 319.006Synthes GmbH · GAUGE, DEPTH899 reports
- NA 03.133.080Synthes GmbH · GAUGE, DEPTH174 reports
- NA 03.010.072Synthes GmbH · GAUGE, DEPTH133 reports
- MULTILOC 03.019.017Synthes GmbH · GAUGE, DEPTH119 reports
- NA 319.01Synthes GmbH · GAUGE, DEPTH113 reports
- NA 319.004Synthes GmbH · GAUGE, DEPTH82 reports
- QUICKSET 2274-60-000Depuy (Ireland) · GAUGE, DEPTH68 reports
- NA 319.09Synthes GmbH · GAUGE, DEPTH65 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.
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