ELITE 7209161Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 03596010448927), received between Jun 5, 2017 and Apr 8, 2026 — classified as 6 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, WHEN PASSING THE SUTURE THREADS, THE CUFF STITCH BENT, AND WHEN IT WAS REMOVED FROM THE JOINT, THE TIP DETACHED. THE PIECE WAS SUCCESSFULLY RETRIEVED FROM INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818875 ↗
• MalfunctionMar 31, 2026Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE CUFF STITCH BROKE INSIDE THE PATIENT DURING SUTURING PROCESS. THE BROKEN PIECE WAS REMOVED FROM INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742217 ↗
• MalfunctionJan 6, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE FOR SHOULDER INSTABILITY, THE TIP OF THE CUFF STITCH BROKE INSIDE THE PATIENT'S SHOULDER. THE FRAGMENT WAS ATTACHED TO A SUTURE THREAD, WHICH HELPED IN ITS COMPLETE REMOVAL, NO PIECES REMAINING INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079431 ↗
• MalfunctionNov 4, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER INSTABILITY PROCEDURE THE TIP OF THE CUFF STITCH 180 DEG LEFT FORCEPS BROKE. THE BROKEN PIECE WAS REMOVE FROM INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SAME FAULTY DEVICE WITH NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20600572 ↗
• MalfunctionNov 1, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER INSTABILITY PROCEDURE THE TIP OF THE CUFF STITCH 180 DEG LEFT FORCEPS BROKE. THE BROKEN PIECE WAS REMOVED FROM INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SAME FAULTY DEVICE WITH NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20587230 ↗
• MalfunctionApr 10, 2024Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A LCA PROCEDURE THE TIP OF THE CUFF STITCH TWEEZER BROKE AND GOT STUCK. THE BROKEN PARTS WERE REMOVED BY SURGEON. THE PROCEDURE WAS COMPLETED WITH THE SAME FAULTY DEVICE WITH NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19081386 ↗
• InjuryMar 31, 2023Break; Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, THE CUFF STITCH CLAMP (CUFF SUTURER) BROKE AT THE TIP DURING THE PASSAGE THROUGH THE LABRUM. THE TIP WAS REMOVED WITH A GRASPER CLAMP. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY BY USING AN ACCU-PASS. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT CURRENT STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16656610 ↗
• InjuryOct 7, 2022Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, AT THE TIME OF PASSING THROUGH THE LADRUM, THE TIP OF THE CUFF STITCH BROKE, THE BROKEN PIECE GOT STUCK IN THE INSTRUMENTAL. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15567906 ↗
• InjuryApr 4, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE CUFF STITCH BROKE. THE BROKEN PIECE WERE REMOVED WITH THE TWEEZER GRASPER. THE PROCEDURE WAS COMPLETED WITHOUT A DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14001103 ↗
• InjuryAug 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE DR. BROKE THE "CUFF STITCH, 180° LEFT". THE BROKEN PIECE WAS SUCCESSFULLY REMOVED FROM THE PATIENT USING A CLAMP. ALTHOUGH THE SURGERY WAS NOT DELAYED, IT IS UNKNOWN IF A BACK-UP DEVICE WAS AVAILABLE. HOWEVER, IT WAS CONFIRMED THE SURGERY WAS SUCCESSFULLY FINISHED. THE PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12305036 ↗
• InjuryJul 21, 2020Material Separation; Material Split, Cut or Torn; Material Separation; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING SHOULDER PROCEDURE, THE CUFF STITCH BROKE WHEN FORCED INSIDE THE LABRUM. THE PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT. NO DELAY AND THE PROCEDURE WAS FINISH WITH THE SAME DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10302415 ↗
• InjuryJun 14, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING ARTHROSCOPY, THE "POINT" OF THE PRODUCT BROKE, THE DOCTOR REMOVED IT WITH THE SUTURE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND NO DELAY WAS REPORTED. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10151614 ↗
• MalfunctionOct 24, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY THE POINT WAS BROKE. PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO DELAY, PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9234196 ↗
• MalfunctionSep 24, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, WHEN THE SUTURE TECHNIQUE WAS PERFORMED, THE FORCEPS BROKE INSIDE THE PATIENT. THE PIECES HAD BEEN REMOVED FROM THE PATIENT. THERE WAS A BACK UP DEVICE AVAILABLE AND NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9109453 ↗
• MalfunctionFeb 12, 2019Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY, THE TIP OF THE CUFF SUTURE BROKE AND GOT CAUGHT IN THE THREAD. IT IS UNKNOWN WHETHER THE BROKEN FRAGMENTS WERE REMOVED OR LEFT INSIDE OF THE PATIENT. A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE, WITH NEITHER SURGICAL DELAY NOR PATIENT INJURIES AS CONSEQUENCES OF THE ALLEGED MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8331079 ↗
• MalfunctionMar 27, 2018Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE INSIDE THE PATIENT, ALL PIECES WERE REMOVED. NO DELAY OR PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7375412 ↗
• MalfunctionMar 9, 2018Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, DUE TO FORCE EXERTED AND EXCESSIVE ANGULATION THE TIP WAS BROKEN AND ALL PARTS WERE REMOVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7328388 ↗
• MalfunctionMar 8, 2018Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE TIPE BROKE DUE TO EXCESSIVE FORCE. ALL PARTS WERE REMOVED. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7323731 ↗
• MalfunctionOct 24, 2017Break

  IT WAS REPORTED DURING THE PROCEDURE THE INSTRUMENT WAS BROKEN, ALL THE PIECES WERE REMOVED FROM THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6975042 ↗
• MalfunctionJun 5, 2017Break; Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE TIP OF THE SUTURE INSTRUMENT BROKE OFF IN THE JOINT. THE BROKEN TIP WAS REMOVED FROM THE PATIENT. A BACKUP DEVICE WAS AVAILABLE T COMPLETE THE PROCEDURE FOLLOWING A DELAY. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6612078 ↗