ELITERecalls & reported problems across all models

We found 9 models of ELITE by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 36 adverse event reports in the FDA's MAUDE database, received between Jun 5, 2017 and Apr 8, 2026 — classified as 9 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Break” (27 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ELITE problems

ELITE models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ELITE 7209161

  ACCESSORIES,ARTHROSCOPIC
  20 reports
• ELITE 72201213

  ACCESSORIES,ARTHROSCOPIC
  4 reports
• ELITE 72202065

  ACCESSORIES,ARTHROSCOPIC
  3 reports
• ELITE 7209154

  ACCESSORIES,ARTHROSCOPIC
  2 reports
• ELITE 7209157

  ACCESSORIES,ARTHROSCOPIC
  2 reports
• ELITE 72202042

  Sterilization wrap containers, trays, cassettes & other accessories
  2 reports
• ELITE 7209153

  ACCESSORIES,ARTHROSCOPIC
  1 report
• ELITE 7209158

  ACCESSORIES,ARTHROSCOPIC
  1 report
• ELITE 72201660

  ACCESSORIES,ARTHROSCOPIC
  1 report

Recent ELITE adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionFeb 9, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, WHEN USING THE OPEN SUTURE CUTTER, THE TIP OF THE INSTRUMENT BROKE OFF .THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS 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 21341266 ↗
• MalfunctionFeb 9, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN CUTTING THE SUTURE, WHEN THE SUTURE CUTTER LOOP WAS FIRED, IT BROKE INSIDE. THE PROCEDURE WAS COMPLETED WITH A CHANGE IN THE SURGICAL TECHNIQUE. NO DELAY WAS REPORTED AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21341198 ↗
• 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 ↗
• MalfunctionDec 23, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SUTURE, AFTER USING THE OSTEORAPTOR ANCHOR, THE DOCTOR WAS GOING TO USE THE FORCEPS TO HELP WITH THE STITCH AND FINISH, BUT THE CUFF STITCH FORCEPS BROKE IN FRAGMENTS. THE BROKEN FORCEPS WERE REMOVED USING A GRASPER FORCEPS. THE SURGEON FINISHED WITH ANOTHER 'BIRDBUCK' FORCEPS, AND NO SURGICAL DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21000232 ↗
• 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 ↗
• MalfunctionOct 15, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE, THE CUT STITCH 30 DEG PINCER BROKE WHEN ATTEMPTING TO PASS THE PINCER THROUGH THE TENDON. THERE WAS NO DELAY AND IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE AVAILABLE. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20450516 ↗
• MalfunctionAug 7, 2024Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER INSTABILITY PROCEDURE, WHEN THE CUFF STITCH WAS BEING USED, THE TIP OF THE CLAMP BROKE AND GOT STUCK, HOWEVER, THE SURGEON WAS ABLE TO REMOVE IT, AND NO BROKEN PART WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SAME CUFF STICH DEVICE REPORTED. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19933450 ↗
• 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 ↗
• MalfunctionFeb 29, 2024Break; Break

  IT WAS REPORTED THAT DURING THE CUFF INSTABILITY PROCEDURE, THE DOCTOR WAS SUTURING THE SHOULDER USING A CUFF STITCH DEVICE AND WAS HAVING DIFFICULTY BENDING THE PASS. WHEN TRYING TO UNTWIST THE TIP IT BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE REPORTED DEVICE. THERE WAS NO SURGICAL DELAY NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18809119 ↗
• 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 ↗
• InjuryDec 15, 2022Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE TIP OF A CUFF STITCH SUTURER BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED; HOWEVER, NO SURGICAL DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15988966 ↗
• 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 ↗

Other Smith & Nephew, Inc. products

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