SURETAC 72201661Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 03596010606297), received between Nov 1, 2017 and Feb 23, 2026 — classified as 7 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Break

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE DOCTOR USED A HAMMER WHILE DETACHING THE LABRUM, AND IT WAS NOTED THAT ONE (1) KNIFE RASP BROKE. THE PROCEDURE WAS RESUMED, WITH A 30 MINUTE DELAY, USING THE SAME DEVICE. THE PIECE WAS REMOVED WITH GRASPERS AND A KELLY CLAMP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414729 ↗
• MalfunctionSep 25, 2025Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPIC PROCEDURE, THE KNIFE RASP BROKE WHILE THE SURGEON WAS SCRAPING THE BONE. NO FRAGMENTS REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23149659 ↗
• InjuryJun 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE TIP OF THE KNIFE RASP BROKE OFF IN THE GLENOID COLON WHEN DETACHING THE LABRUM FROM THE GLENOID. THREE ATTEMPTS WERE MADE TO REMOVE THE TIP, BUT THERE WAS NO SUCCESS AS THE SCRAPER FRAGMENT WAS FIXED IN THE GLENOID. THE LABRUM WAS SUCCESSFULLY REPAIRED. THERE WAS A DELAY OF 15 MINUTES REPORTED AND THE PROCEDURE WAS COMPLETED USING THE SAME FAULTY DEVICE, NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22290517 ↗
• MalfunctionJun 3, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE KNIFE RASP BROKE DURING THE SCRAPING AND DETACHMENT OF THE TENDON, NORMAL FORCE BENT AND BROKE IT. THE BROKEN TIP WAS COMPLETELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING THE SAME FAULTY DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19454241 ↗
• MalfunctionMay 27, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, WHEN PERFORMING THE PROCEDURE OF THE ROTATOR CUFF, WHEN INSERTING IT INTO THE HUMMERS, THE TIP OF THE KNIFE RASP BROKE. THE SURGEON REMOVED THE PIECE OF METAL WITH THE HELP OF A GRASPER. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19402320 ↗
• InjuryMar 6, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY WITH A KNIFE RASP, WHEN DETACHING THE TENDON, THE CLAMP BROKE, LEAVING A PART OF IT INSIDE THE PATIENT. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT WITH THE HELP OF A GRASPER. 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 16491641 ↗
• InjuryNov 2, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE DOCTOR FORCED THE RASP INSIDE THE PATIENT'S SHOULDER TO TRIED TO RELEASE THE TENDON, HOWEVER, IT WAS NOT POSSIBLE AND THE DUE TO THE FORCING IT BROKE. IT WAS ALL REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15718002 ↗
• InjurySep 27, 2022Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, A KNIFE RASP BROKE, WHILST BEING USED TO REMOVE TISSUE. ALL THE BROKEN PIECES WERE REMOVED. SURGERY RESUMED WITHOUT ANY DELAY WITH THE SAME DEVICE. PATIENT´S HEALTH STATUS IS STABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15491740 ↗
• MalfunctionMar 30, 2022Crack; Crack

  IT WAS REPORTED THAT THE ELITE, KNIFE WAS FOUND CRACKED DURING INSPECTION AT THE HOSPITAL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13955916 ↗
• InjuryOct 21, 2021Break; Break

  IT WAS REPORTED THAT DURING ARTHROSCOPY PROCEDURE, INSIDE THE PATIENT, THE KNIFE RASP BROKE OFF AND WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12677316 ↗
• MalfunctionAug 6, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY USING AN "ELITE PREMIUM KNIFE RASP", THE HANDLE BROKE OUTSIDE THE PATIENT. ALTHOUGH THE SURGERY WAS NOT DELAYED, IT IS UNKNOWN IF A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HANDLE HAS BECOME BROKEN FROM THE KNIFE, RASP, SHAFT WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12288241 ↗
• InjuryJul 4, 2021Break; Break

  IT WAS REPORTED THAT DURING A LABRUM SURGERY, THE DETACHER OF THE ELITE KNIFE RASP BROKE. THE PIECE WAS REMOVED WITH GRASPER. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12114607 ↗
• InjuryMar 22, 2021Break; Break

  IT WAS REPORTED THAT DURING SURGERY, AFTER USE WHEN PASSING IT THROUGH THE CANNULA, THE ELITE PREMIUM KNIFE RASP STARTED TO PEEL OFF AND BROKE. NO DELAY OR OTHER COMPLICATIONS WERE REPORTED. IT IS UNKNOWN IF THERE WAS A BACKUP AVAILABLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11547747 ↗
• MalfunctionJan 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, WHEN THE DOCTOR WAS TAKING OFF THE LABRUM, THE KNIFE RASP BROKE, BROKEN PIECES WERE REMOVED WITH TWEEZERS. NO SIGNIFICANT DELAY OR PATIENT INJURIES WERE REPORTED. IT IS UNKNOWN IF A BACKUP DEVICE WAS AVAILABLE. 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 9580513 ↗
• MalfunctionDec 23, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE WHEN THE DOCTOR WAS TAKING OFF THE TENDON, THE CLAMP TAPE CABLE BROKE INSIDE THE PATIENT, ALL PIECES WERE REMOVED. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED. IT IS UNKNOWN IF THERE WAS A BACKUP DEVICE AVAILABLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9513209 ↗
• MalfunctionNov 4, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, WHEN SCRAPING THE CUFF, THE KNIFE BROKE INTO THE MIDDLE. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. THERE WAS NO DELAY OR PATIENT INJURIES BUT IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED SINCE NO BACKUP DEVICE WAS AVAILABLE TO COMPLETE IT. 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 9272635 ↗
• MalfunctionJul 17, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE PRODUCT BROKE NEAR OF THE CABLE DUE TO THE EXCESS OF FORCE WHEN PUSHING THE FRAGMENT. THE PIECE WAS BEEN REMOVED FROM THE PATIENT WITH A CLAMP. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.

  Patient problems: Foreign Body In Patient

  MAUDE report 8800051 ↗
• MalfunctionJul 4, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SHOULDER SURGERY THE DEVICE BROKE INTO THREE PIECES. IT IS UNKNOWN WHETHER THERE WAS A BACKUP DEVICE AVAILABLE. NO DELAY OR PATIENT INJURY WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8762785 ↗
• MalfunctionMay 14, 2019Break

  IT WAS REPORTED THAT DURING THE SURGERY THE DOCTOR USED THE HAMMER TO HIT THE CLAMP AND THE CLAMP GOT BROKEN. NO PATIENT'S INJURIES OR DELAY WERE REPORTED. BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT'S ANATOMY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8608783 ↗
• MalfunctionNov 7, 2018Break

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN DETACHING THE TENDON THE BREAKER BROKE. THERE WAS NO DAMAGE TO THE PATIENT AND ALL PARTS WERE REMOVED FROM THE PATIENT. THERE WAS NO BACKUP DEVICE AVAILABLE. NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8046032 ↗
• MalfunctionJan 10, 2018Break

  IT WAS REPORTED THAT DURING SURGICAL PROCEDURE DEVICE BROKE. PIECES WERE SUCCESSFULLY REMOVED WITH NO PATIENT INJURIES. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7179586 ↗
• MalfunctionNov 1, 2017Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6995267 ↗