Arthrex® AR-8967-1895Recalls & reported problems
Arthrex, Inc. · LOW PRO SCRW,TI,6.7X 95MMCANN,18MM THD · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867056183), received between Feb 23, 2017 and Feb 23, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
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
Device problems
- Break1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 23, 2017Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRIPLE ARTHRODESIS PROCEDURE ON (B)(6) 2016. AROUND (B)(6) 2016, THE PATIENT NOTICED DRAINAGE FROM A SMALL OPENING IN HIS LEFT LATERAL FOOT INCISION. THE PATIENT TESTED POSITIVE FOR PREVOTELLA DISIENS BETA LACTAMASE AND TESTED NEGATIVE FOR FINEGOLDIA MAGNA BETA LACTAMASE AND GEMELLA MORBILLORUM BETA LACTAMASE. THE PATIENT WAS PRESCRIBED 500MG OF KEFLEX TWICE A DAY FOR 7 DAYS. SURGEON HAD PLANNED A REVISION TO REMOVE ONLY THE TWO 4.5MM SCREWS THAT WERE IN CLOSEST PROXIMITY TO THE INFECTED AREA HOWEVER, THE PATIENT'S INFECTION CONTROL DOCTOR WANTED FOR ALL THE HARDWARE TO BE REMOVED. REVISION TOOK PLACE (B)(6) 2017. WHILE REMOVING THE HARDWARE FROM THE (B)(6) 2016 TRIPLE ARTHRODESIS, THE TIP OF THE 3.5 CANNULATED HEX DRIVER, AR-8967D, LOT UNKNOWN, ((B)(4)) BROKE INTO MULTIPLE PIECES. THE SURGEON HAD STARTED THE REMOVAL OF THE 6.7MM SCREW WITH THE DRIVER ON A RATCHETING HANDLE, AND ON HIS FIRST ATTEMPT OF USING POWER, THE HEX DRIVER BROKE. ALL PIECES WERE REMOVED AND ACCOUNTED FOR EXCEPT FOR ONE, IT WAS NOT FOUND IN THE STERILE FIELD AND THE SURGEON COULD NOT SEE ANYTHING LARGE ENOUGH ON X-RAY TO GO AFTER BEFORE CLOSING. THE SCRUB TECH HAD
Patient problems: Foreign Body In Patient
MAUDE report 6352221 ↗
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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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