Arthrex® AR-1655PSRecalls & reported problems
Arthrex, Inc. · TENO SCRW,PEEK · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867020504), received between Jun 2, 2017 and Jul 10, 2023 — classified as 1 injury, 1 malfunction.
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 18, 2026.
Most reported problems
Device problems
- Break1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Tissue Damage1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2023Break; Break
ON 6/12/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1655PS PEEK TENODESIS SCREW BROKE. IT WOULD NOT SEAT PROPERLY ON THE INSERTER. THIS WAS DISCOVERED DURING AN AC JOINT REPAIR PROCEDURE ON (B)(6)2023. ADDITIONAL INFORMATION REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17287583 ↗InjuryJun 2, 2017Insufficient Device Problem Information
IT WAS ORIGINALLY REPORTED THAT THE PATIENT UNDERWENT AN AC JOINT RECONSTRUCTION ON THE RIGHT SHOULDER. THE PATIENT SCHEDULED AN APPOINTMENT WITH HIS SURGEON TO IDENTIFY SOMETHING "FUNNY" IN HIS SHOULDER. THE SURGEON WAS ABLE TO REMOVE SOME SCREWS AND THE SUTURE FROM THE SURGERY. THE SURGEON PLANS ON GOING IN WITH A SCOPE TO CLEAN OUT THE PATIENT'S SHOULDER. ORIGINAL PART NUMBER INFORMATION WAS NOT KNOWN AT TIME OF REPORT AND HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED (B)(6) 2017: ORIGINAL DATE OF IMPLANT AC JOINT RECONSTRUCTION SURGERY WAS (B)(6) 2015. PART AR-1655PS, LOT 1257190, QTY 2 WERE IMPLANTED DURING THE 2015 PROCEDURE. THE SUTURE AND SCREW THAT WERE REMOVED FROM THE PATIENT WERE REMOVED IN THE SURGEON'S OFFICE. SURGEON WAS ABLE TO PULL THE SUTURE OUT ALONG WITH THE SCREW HIMSELF AFTER MAKING A SMALL INCISION. ONLY ONE SCREW IS KNOWN TO HAVE BEEN REMOVED. THE SURGEON HAS DECIDED NOT TO SCHEDULE ANOTHER PROCEDURE, AS THE PATIENT HAS NOT RETURNED COMPLAINING OF ANY PAIN.
Patient problems: Tissue Damage
MAUDE report 6607847 ↗
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
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- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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