Arthrex® AR-7200SRRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867041271), received between Jul 24, 2018 and Jan 6, 2025 — classified as 2 injuries, 2 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2025Material Twisted/Bent; Material Twisted/Bent

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-7200SR SABRE BLADE IS BENDING AND WILL NOT WORK. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21080818 ↗
• MalfunctionNov 30, 2021Break

  IT WAS REPORTED THAT ANKLE ARTHROSCOPY WITH LATERAL LIGAMENT REPAIR WHILE DEBRIDING THE SOFT TISSUE THE TIP OF THE SHAVER BLADE BROKE OFF. THE FRAGMENTS WERE RETRIEVED BY THE SURGEON USING AN ARTERY CLIP. THE SURGEON REPORTED THAT THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12896885 ↗
• InjurySep 21, 2020Material Separation

  IT WAS REPORTED (VIA FDA MEDWATCH LETTER MW5095971) THAT THE FOLLOWING INCIDENT HAD BEEN REPORTED BY THE FACILITY: A LAPAROSCOPIC PROCEDURE WAS PERFORMED WITHOUT ANY NOTICEABLE ISSUES. A DISPOSABLE ARTHREX SABRE TYPE SHAVER WAS USED. THIS SHAVER IS 7CM LONG WITH A 2MM TIP ENCLOSED IN A SHEATH. BOTH THE ATTENDING SURGEON AND THE SURGICAL RESIDENT HAD USED THE ARTHREX SABRE TYPE SHAVER BEFORE WITHOUT ANY ISSUES. WHEN THE RESIDENT WAS DONE USING THE SHAVER HE EXTRACTED IT AS ONE UNIT. UNBEKNOWNST TO THE SURGICAL TEAM A PIECE OF THE SHAVER, APPROXIMATELY 5 CM LONG, HAD BROKEN DURING USE AND WAS STILL INSIDE THE PATIENT'S ANKLE TISSUE. THEE WAS NO PERCEPTIBLE FEELING OR INDICATION OF DEVICE FAILURE. WHEN REMOVED FROM THE PATIENT, IT WAS PULLED OUT WITHIN THE SHEATH AND APPEARED TO BE NORMAL. WHILE IN THE PACU A POST OP X-RAY WAS TAKEN AS THIS WAS THE REGULAR PRACTICE OF THE SURGEON IN ORDER TO REVIEW THE ANKLE POST PROCEDURE. THE POST OP X-RAY IN THE PACU REVEALED AN ARTIFACT WHICH WAS DETERMINED TO BE THE TIP OF THE SHAVER. THE BROKEN FRAGMENT WAS REMOVED IN STERILE ASPECT MANNER IN THE PACU WITHOUT INCIDENT. X-RAYS WERE REPEATED TO ENSURE THE ENTIRE TIP PIECE WAS REMOVED. DEVICE REPOR

  Patient problems: Foreign Body In Patient

  MAUDE report 10563004 ↗
• InjuryJul 24, 2018Material Integrity Problem

  IT WAS REPORTED THAT DURING A HAND ARTHROSCOPY THE DEVICE PRODUCED METAL ABRASION. THE SURGEON IS NOT SURE IF FRAGMENTS WILL REMAIN INSIDE THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH THIS DEVICE AND THERE WAS NO HARM FOR PATIENT, USER OR THIRD PARTY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7713361 ↗