NA 7209485Recalls & reported problems

Summary

The FDA's MAUDE database contains 202 adverse event reports that list this exact device (DI 03596010468482), received between Nov 21, 2017 and Mar 30, 2026 — classified as 26 injuries, 176 malfunctions.

The most frequently reported specific device problem is “Break” (141 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 202 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT, DURING SURGERY, WHEN PULL OUT THE SUTURE WITH ONE (1) MENISCUS MENDER II, THE WIRE OF LOOP RETRIEVER BROKE EASILY. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT; HOWEVER, IT IS UNKNOWN HOW THEY WERE RETRIEVED.THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24736181 ↗
• MalfunctionDec 1, 2025Break; Break

  IT WAS REPORTED THAT, DURING A RIGHT KNEE MENISCUS REPAIR, THE METAL LOOP OF A MENISCUS MENDER INSERTER BROKE. BOTH THE INSERTER AND METAL LOOP WERE RECOVERED. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687529 ↗
• MalfunctionJul 15, 2024Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A KNEE SURGERY, AS THE LASSO OF THE SET MENISCUS MENDER PASSED THROUGH THE PATIENT'S KNEE, THE SURGEON FELT A BLOCKAGE. HE THEN COMPLETED HIS WIRE PASSAGE, AND WHEN HE PULLED OUT THE LASSO, A NEW BLOCKAGE OCCURRED AT THE ENTRANCE TO THE PUNCTURE POINT. AFTER SEVERAL MANIPULATIONS, THE NEEDLE FINALLY EXITED THE KNEE, BUT WITHOUT THE LASSO, WHICH REMAINED BLOCKED AT THE ENTRANCE TO THE KNEE. THE LASSO WAS RECOVERED FROM THE PATIENT USING FORCEPS. THE PROCEDURE WAS COMPLETED WITH AN UNKNOWN SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19740154 ↗
• MalfunctionApr 30, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY, THE LASSO OF THE SET MENISCUS MENDER WAS INTRODUCED INTO THE NEEDLE PUT INTO THE KNEE OF THE PATIENT TO GET BACK A THREAD. BY TRYING TO REMOVE THE SYSTEM, THE TIP OF THE LASSO REMAINED IN TO THE PATIENT KNEE. THE SURGEON SUCCEEDED TO GET IT BACK (NO DAMAGE FOR THE PATIENT). THE PROCEDURE WAS COMPLETED WITH A DELAY OF 15 MINUTES. THERE IS NO INFORMATION AVAILABLE OF THE BACK UP OF THE SET MENISCUS MENDER. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19215590 ↗
• MalfunctionFeb 23, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE MENDER LOOP OF THE MENDER II WAS BROKEN INSIDE THE BOX. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18768980 ↗
• MalfunctionDec 14, 2023Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, WHERE A SET MENISCUS MENDER II WAS USED, IT WAS NOT POSSIBLE TO PASS THE SUTURE THROUGH THE NEEDLE. SURGERY CONTINUED WITHOUT ANY DELAY WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. AS PER INVESTIGATION RESULTS THE SUTURE RETRIEVER WAS NOT FUNCTIONAL DUE TO ONE SNARE BEING FRACTURED FROM THE HUB AND BOTH SNARE LOOPS BEING DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18326229 ↗
• MalfunctionNov 23, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE SET MENISCUS MENDER II WAS BROKEN WHEN THE PACKAGE WAS OPENED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18198490 ↗
• MalfunctionAug 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE LOOP RETRIEVER OF A SET MENISCUS MENDER WAS SOON DISASSEMBLED BETWEEN HEAD AND SHAFT WHEN IT WAS USED; HOWEVER IT WAS NOT NECESSARY TO BE RETRIEVED FROM THE PATIENT. SURGERY RESUMED AFTER A NON-SIGNIFICANT DELAY OF 5 MINUTES; WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17558513 ↗
• MalfunctionAug 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE, THE LOOP RETRIEVER OF THE MENISCUS MENDER SET WAS DISASSEMBLED BETWEEN HEAD AND SHAFT WHEN THE PACKAGE WAS OPENED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE USING 1 OF THE 2 LOOP RETRIEVERS IN THE SAME BOX. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17472163 ↗
• MalfunctionJul 11, 2023Break; Break

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR PROCEDURE, THE DISTAL WIRES OF THE MENISCUS MENDER II BROKE AND FELL INTO THE PATIENT'S JOINT. THE PIECES WERE REMOVED FROM THE PATIENT WITH A GRIPPER. SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17301794 ↗
• MalfunctionJun 8, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE SET MENISCUS MENDER II DISPOSABLE WAS BROKEN UPON OPENING THE PRODUCT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17090187 ↗
• MalfunctionApr 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A MENISCUS PROCEDURE, THE LOOP RETRIEVER OF THE MENISCUS MENDER WAS DISASSEMBLED BETWEEN HEAD AND SHAFT WHEN THE PACKAGE WAS OPENED. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16746788 ↗
• MalfunctionFeb 1, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY WHEN TRYING TO INSERT THE SET MENISCUS MENDER II DISPOSABLE, THE NEEDLE BROKE. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16280003 ↗
• MalfunctionJan 9, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE MENISCUS MENDER SET WAS BROKEN WHEN THE PACKAGE WAS OPENED. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE, HOWEVER IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16120779 ↗
• MalfunctionJan 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SET UP FOR AN ARTHROSCOPY, THE SURGEON ATTEMPTED TO PULL THE COMPONENTS OF THE MENISCUS MENDER II OUT OF THE PLASTIC PACKAGING AND THEY BROKE. A BACK-UP DEVICE WAS AVAILABLE AND A NON-SIGNIFICANT SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16084048 ↗
• MalfunctionNov 14, 2022Break; Break

  IT WAS REPORTED THAT, DURING A MENISCAL REPAIR PROCEDURE, THE MENISCUS MENDER BROKE AS IT WAS REMOVED FROM THE PLASTIC HOLDER. THE PROCEDURE WAS COMPLETED WITH A SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15794387 ↗
• MalfunctionNov 14, 2022Break; Break

  IT WAS REPORTED THAT, DURING A MENISCAL REPAIR PROCEDURE, TWO (2) MENISCUS MENDER SETS BROKE. THE FIRST BROKE OFF WHEN IT WAS INSERTED INTO THE NEEDLE. THE SECOND, BOTH WIRE LOOPS WERE REMOVED AND ALSO BROKE WITH NO FORCE. THE PROCEDURE WAS COMPLETED WITH A SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15793434 ↗
• MalfunctionNov 8, 2022Break; Break

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR SURGERY, WHEN TRIED TO TAKE OUT THE NEEDLES OF THE SET MENISCUS MENDER OUT OF THE PACK, BOTH NEEDLES SNAPPED. NON-SIGNIFICANT DELAY WAS REPORTED, AND IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15755523 ↗
• MalfunctionOct 31, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE MENISCUS MENDER SET WAS BROKEN INSIDE THE PACKAGE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15699664 ↗
• MalfunctionJul 18, 2022Fracture; Difficult to Insert; Fracture; Difficult to Insert

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, IT WAS NOT POSSIBLE TO INSERT THE LOOP RETRIEVER OF THE MENISCUS MENDER TO THE OUTER SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. PER INVESTIGATION IT WAS FOUND THAT ONE OF THE SUTURE THREADERS HAS THE DISTAL END (SNARE) DEFORMED AND IS FRACTURED BETWEEN THE HUB AND THE SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15039330 ↗
• InjuryJun 30, 2022Break; Break

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR, THE MENISCUS MENDER SUTURE LOOP WAS BROKEN. IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN UNKNOWN INTERVAL OF DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14875549 ↗
• MalfunctionJun 15, 2022Break; Break

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR, THE MENISCUS MENDER BROKE, IT COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14701380 ↗
• InjuryMay 24, 2022Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPIC PROCEDURE, THE SNARE OF THE MENISCUS MENDER SET WAS FOUND BROKE OFF AFTER INTRODUCING IT INTO KNEE JOINT, THE BROKEN PARTS WERE REMOVED FROM PATIENT¿S JOINT USING A GRASPER. THIS RESULTED IN A NON-SIGNIFICANT SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH USING A NEW MENDER BACK-UP DEVICE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14491070 ↗
• MalfunctionMay 17, 2022Break; Break

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, INSTRUMENTS OUTSIDE PATIENT, THE NEEDLE WAS FOUND TO BE ALREADY BROKEN WHEN THE PACKAGE WAS OPENED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14420916 ↗
• MalfunctionApr 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR PROCEDURE, THE LOOP RETRIEVERS OF THE 'MENISCUS MENDER II' WERE DISASSEMBLED BETWEEN HEAD AND SHAFT WHEN THE PACKAGE WAS OPENED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14197804 ↗