Arthrex® AR-7900Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867300453), received between Sep 4, 2019 and Nov 9, 2023 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGERY THE DEVICE AR-7900 (LOT: 15037948) DIDN'T TAKE THE NEEDLE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE FROM ANOTHER MANUFACTURER. IT WAS NOT NECESSARY TO DO A SECOND SURGERY. UPDATE AVOE 18-OCT-2023 IT WAS CONFIRMED THAT THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE FROM ANOTHER MANUFACTURER AND IT WAS NOT NECESSARY TO SWITCH THE SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18102069 ↗
• MalfunctionDec 27, 2022Failure to Advance

  IT WAS REPORTED THAT DURING A MENISCUS SURGERY THE NEEDLE COULD NOT BE ADVANCED AND SO THE SYSTEM INCLUDING THE AR-7905, AR-7910L AND AR-7900 DID NOT WORK. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE BY CHANGING TO AN OUTSIDE-IN PROCEDURE. IT WAS NOT NECESSARY TO SWITCH THE GENERAL SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16052112 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT GOT AN INFECTION AFTER HE WAS TREATED WITH THE DEVICES AR-7900 (LOT: 10822462), AR-7910L (LOT: 928497924) AND AR-7523 (LOT: 934399472). THIS WAS NOTICED AFTER THE SURGERY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Unspecified Infection

  MAUDE report 11842561 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT GOT AN INFECTION AFTER HE WAS TREATED WITH THE DEVICES AR-7900 (LOT: 10822462), AR-7910L (LOT: 928497924) AND AR-7523 (LOT: 934399472). THIS WAS NOTICED AFTER THE SURGERY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Unspecified Infection

  MAUDE report 11842384 ↗
• InjurySep 4, 2019Failure to Advance; Separation Failure; Material Twisted/Bent

  IT WAS REPORTED DURING AN INSIDE-OUT MENISCAL REPAIR PROCEDURE, THE SURGEON USED TWO AR-7900 ZONE NAVIGATORS (LOT: 10297141 AND LOT: 10302082). THE REP STATED BOTH DEVICES MALFUNCTIONED IN THE SAME PROCEDURE. HOWEVER, IT IS UNKNOWN WHICH ISSUE OCCURRED WITH EACH SPECIFIC LOT. DURING THE PROCEDURE THE SURGEON OPENED ONE AR-7900 AND A MID-POSTERIOR CANNULA. AFTER SLIDING THE CANNULA ON TOP, THE SURGEON NEEDED TO ADJUST THE CANNULA. UPON ATTEMPTING TO ADJUST THE CANNULA, IT WAS EXTREMELY DIFFICULT TO TAKE OFF THE CANNULA WITH THE GREY BUTTON DEPRESSED ALL THE WAY DOWN ON THE HANDLE. A SECOND AR-7900 WAS OPENED AND THE CANNULA WAS ABLE TO BE ADJUSTED MUCH BETTER. HOWEVER, THE NEEDLE WAS BENT AND NOT SLIDING EASILY INTO THE HANDPIECE SO THE SURGEON SWITCHED HANDPIECES WITH THE RECOMMENDATION TO USE FRESH NEEDLES. AS THE SURGEON SLID THE NEEDLE THROUGH AND TRIED TO ADVANCE IT, THE TOLERANCE WAS EXTREMELY TIGHT AND THE NEEDLE WOULD NOT ADVANCE THROUGH. AT THIS POINT THE SURGEON THEN SWITCHED TO AN OUTSIDE-IN TECHNIQUE DUE TO ONLY HAVING ONE TECH SCRUBBED IN. THE SALES REP REPORTED THERE WAS NO HARM TO THE PATIENT. THE REP CONFIRMED NO INSTRUMENT BROKE INSIDE THE PATIENT. ADDITIONAL INFORM

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8961163 ↗
• InjurySep 4, 2019Failure to Advance; Separation Failure; Material Twisted/Bent

  IT WAS REPORTED DURING AN INSIDE-OUT MENISCAL REPAIR PROCEDURE, THE SURGEON USED TWO AR-7900 ZONE NAVIGATORS (LOT: 10297141 AND LOT: 10302082). THE REP STATED BOTH DEVICES MALFUNCTIONED IN THE SAME PROCEDURE. HOWEVER, IT IS UNKNOWN WHICH ISSUE OCCURRED WITH EACH SPECIFIC LOT. DURING THE PROCEDURE THE SURGEON OPENED ONE AR-7900 AND A MID-POSTERIOR CANNULA. AFTER SLIDING THE CANNULA ON TOP, THE SURGEON NEEDED TO ADJUST THE CANNULA. UPON ATTEMPTING TO ADJUST THE CANNULA, IT WAS EXTREMELY DIFFICULT TO TAKE OFF THE CANNULA WITH THE GREY BUTTON DEPRESSED ALL THE WAY DOWN ON THE HANDLE. A SECOND AR-7900 WAS OPENED AND THE CANNULA WAS ABLE TO BE ADJUSTED MUCH BETTER. HOWEVER, THE NEEDLE WAS BENT AND NOT SLIDING EASILY INTO THE HANDPIECE SO THE SURGEON SWITCHED HANDPIECES WITH THE RECOMMENDATION TO USE FRESH NEEDLES. AS THE SURGEON SLID THE NEEDLE THROUGH AND TRIED TO ADVANCE IT, THE TOLERANCE WAS EXTREMELY TIGHT AND THE NEEDLE WOULD NOT ADVANCE THROUGH. AT THIS POINT THE SURGEON THEN SWITCHED TO AN OUTSIDE-IN TECHNIQUE DUE TO ONLY HAVING ONE TECH SCRUBBED IN. THE SALES REP REPORTED THERE WAS NO HARM TO THE PATIENT. THE REP CONFIRMED NO INSTRUMENT BROKE INSIDE THE PATIENT. ADDITIONAL INFORM

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8961134 ↗