Arthrex® AR-1662PSL-710Recalls & reported problems
Arthrex, Inc. · PEEK SwiveLock Biceps Teno, 7 X 10 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867293151), received between May 3, 2024 and Jun 10, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 10, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ON 05/09/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1662PSL-710 SWIVELLOCK IMPLANT WORKED FINE, BUT SURGEON PROCEDURE LED TO THE IMPLANT CUTTING THE SUTURE ON TOP. CLAIMS THAT FIBERWIRE IS SHARP ENOUGH TO CUT THE SUTURE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19505383 ↗MalfunctionJun 10, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ON 05/09/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1662PSL-710 SWIVELLOCK IMPLANT WORKED FINE, BUT SURGEON PROCEDURE LED TO THE IMPLANT CUTTING THE SUTURE ON TOP. CLAIMS THAT FIBERWIRE IS SHARP ENOUGH TO CUT THE SUTURE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19505220 ↗MalfunctionMay 3, 2024Break; Break
ON 08-AUG-2022, IT WAS REPORTED BY A SALES REP VIA EMAIL THAT A AR-1662PSL-710, PEEK SWIVELOCK BICEPS TENO, 7 X 10 WAS CUT BY THE END OF THE SWIVELOCK DRIVER. THIS WAS DISCOVERED DURING USE AND A CASE WAS INVOLVED. NO INFORMATION WAS PROVIDED ON HOW THE PROCEDURE WAS COMPLETED.
Patient problems: Insufficient Information
MAUDE report 19237278 ↗
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- 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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