NA 251723Recalls & reported problems

Summary

The FDA's MAUDE database contains 145 adverse event reports that list this exact device (DI 10886705012312), received between May 23, 2018 and Mar 26, 2026 — classified as 4 injuries, 141 malfunctions.

The most frequently reported specific device problem is “Break” (42 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 145 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT DURING ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) PROCEDURE, THE METAL TIP OF THE IDEAL SUTGRASPER 60 DEG BROKE, RENDERING IT UNUSABLE. A NEW ONE WAS OPENED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. IT HAS BEEN CONFIRMED THAT NO FRAGMENTS OF THE BROKEN METAL REMAIN IN THE BODY. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700038 ↗
• MalfunctionJul 18, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE IDEAL SUTGRASPER 60 DEG DEVICE END OF HOOK ON SUTURE GRASPER BROKE WHILE IN USE. BROKEN PIECE MEASURES 3MM LONG AND IS APPROXIMATELY AS THICK AS A 5-0 SUTURE. SURGEON UNABLE TO LOCATE PIECE, FURTHER SEARCHING MAY HAVE CAUSED DAMAGE, MAY POSSIBLY HAVE BEEN WASHED OUT. THE ITEM IN QUESTION IS VERY MICRO AND CANNOT BE DETECTED WITH AN X-RAY. THE SURGEON WAS MADE AWARE AND CANNOT SAY FOR CERTAIN THE LOCATION OF THE MISSING PIECE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22541470 ↗
• MalfunctionJul 17, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE FOR A TEAR ON THE LEFT SHOULDER, THE SURGEON PLANNED TO USE THE IDEAL SUTGRASPER 60 DEG DEVICE FOR PASSING A SUTURE. THE SURGEON INSPECTED THE MOVEMENT OF THE THUMB SLIDE OF THE DEVICE AND OBSERVED THAT THE THUMB SLIDE WOULD NOT RETURN TO ITS ORIGINAL POSITION, AND THE DEVICE COULD NOT BE USED. IT WAS REPORTED THAT THE SURGEON USED ANOTHER NEW DEVICE. THERE WAS NO HARM TO THE PATIENT AND NO SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22535913 ↗
• MalfunctionJul 14, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT THE IDEAL SUTGRASPER 60 DEG EA DEVICE INNER AND OUTER BOX WERE PUNCTURED. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22498955 ↗
• MalfunctionJul 1, 2025Use of Device Problem; Difficult to Open or Close; Use of Device Problem; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS OBSERVED THAT THE SURGEON PUNCTURED THE IDEAL SUTGRASPER 60 DEG DEVICE THROUGH THE TISSUE AND ATTEMPTED TO MAKE THE TIP COME OUT OF THE DEVICE, BUT THE TIP DID NOT COME OUT OF THE DEVICE. ACCORDING TO THE REPORTER, THE SURGEON ALSO TRIED THE SAME OPERATION ON THE DEVICE OUTSIDE THE BODY, BUT IT DID NOT WORK. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22370173 ↗
• MalfunctionJun 17, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY/ROTATOR CUFF REPAIR PROCEDURE, THE TWO (X2) IDEAL SUTGRASPER 60 DEG DEVICES WERE BENT AT A GREATER ANGLE THAN USUAL AND WERE NOT NEARLY AS SHARP AS THEY USUALLY ARE. IT WAS REPORTED THAT THERE WAS A DELAY OF SEVERAL MINUTES AND THEY OPENED ANOTHER BOX. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22236392 ↗
• MalfunctionJun 17, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY/ROTATOR CUFF REPAIR PROCEDURE, THE TWO (X2) IDEAL SUTGRASPER 60 DEG DEVICES WERE BENT AT A GREATER ANGLE THAN USUAL AND WERE NOT NEARLY AS SHARP AS THEY USUALLY ARE. IT WAS REPORTED THAT THERE WAS A DELAY OF SEVERAL MINUTES AND THEY OPENED ANOTHER BOX. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22236390 ↗
• MalfunctionJun 9, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A SHOULDER INSTABILITY PROCEDURE, IT WAS FOUND THAT THE METAL TIP OF THE IDEAL SUTGRASPER 60 DEG DEVICE WAS BENT AND COULD NO LONGER BE USED. THERE WERE NO DELAYS DURING THE SURGICAL PROCEDURE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169233 ↗
• MalfunctionMay 6, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY, IT WAS OBSERVED THAT WHEN THE IDEAL SUTGRASPER 60 DEG DEVICE WAS INSERTED IN TO THE TENDON, THE TIP WAS BENT SO MUCH THAT IT NO LONGER COULD BE USED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21966599 ↗
• MalfunctionFeb 6, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHEN THE SURGEON GRASPED THE SUTURE AND ATTEMPTED TO PULL IT OUT, THE WIRE ON THE IDEAL SUTGRASPER 60 DEG *EA DEVICE BENT AND BECAME UNUSABLE. IT WAS ASSUMED TO LACK SUFFICIENT STRENGTH. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21321440 ↗
• MalfunctionSep 4, 2024Degraded; Material Deformation; Degraded; Material Deformation

  IT WAS REPORTED FROM HONG KONG THAT DURING A BANKART REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE IDEAL SUTGRASPER 60 DEG DEVICE WAS TOO BLUNT, PREVENTING THE SURGEONS FROM USING IT TO PENETRATE THE SOFT TISSUES. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS DEFORMED/BENT. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20136673 ↗
• MalfunctionMar 25, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 THE IDEAL SUTGRASPER DEVICE SHAFT PART WAS EASILY BENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO BROKEN PIECES IN THE BODY. THERE WAS NO SURGICAL DELAY TO THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18970545 ↗
• MalfunctionMar 12, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING AN ANTERIOR ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2024 THE IDEAL SUT GRASPER 60 DEG *EA DEVICE HAD A PERMATAPE INSERTED INTO THE HUMERAL HEAD. THE SUTURE GRASPER IN QUESTION WAS USED WHEN APPLYING THE LOADED PERMATAPE TO THE ROTATOR CUFF. WHEN THE TAPE WAS APPLIED TO THE ROTATOR CUFF USING THE SUTURE GRASPER IN QUESTION, THE TAPE DID NOT SLIDE SMOOTHLY WITHIN THE ANCHOR. IT CAUSED A STRONG RESISTANCE. THE CLIP MECHANISM IN THE SUTURE GRASPER FAILED AND PARTIALLY BROKE OFF. AFTER THE PROCEDURE WAS COMPLETED, THE IMAGE SHOWED THAT THE BROKEN PIECE REMAINED INSIDE THE BODY BEFORE THE WOUND WAS CLOSED. THE SURGEON DETERMINED THAT REMOVAL WAS NOT POSSIBLE AND THAT THE POSSIBILITY OF HEALTH HAZARD WAS EXTREMELY LOW, SO THAT THE SURGERY WAS COMPLETED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. ACCORDING TO THE SURGEON, IF PERMATAPE IS APPLIED TO THE ROTATOR CUFF USING A SUTURE GRASPER, THERE IS A VERY HIGH RISK THAT THE CLIPS IN THE SUTURE GRASPER WILL BREAK OFF DUE TO THE RESISTANCE OF THE TAPE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18889269 ↗
• MalfunctionJan 5, 2024Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023 THE IDEAL SUTGRASPER 60 DEG DEVICE TIPS WERE DAMAGED, AND THE BROKEN FRAGMENTS REMAINED IN THE PATIENT'S BODY. IT WAS REPORTED THAT THERE WERE TWO BROKEN FRAGMENTS AND ONE OF THEM MAY BE A FRAGMENT OF THE TIP OF THE SUTURE GRASPER IN ADDITION TO THE FRAGMENT OF THE EDGE'S. ON (B)(6) 2023, AN EXTRA PRODUCT (IDEAL SUTGRASPER 60 DEG) WAS RECEIVED FOR EVALUATION AS A BLIND UNIT. DURING IN-HOUSE ENGINEERING EVALUATION OF THE BLIND UNIT, IT WAS OBSERVED THAT THE DEVICE HAD NO ANOMALIES ON THE HANDLE AND SHAFT. THE GRASPING WIRE WAS DAMAGED AT THE TIP. THE TIP WAS BENT, AND A LITTLE PIECE OF THE DISTAL TIP WAS BROKEN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18451078 ↗
• MalfunctionNov 29, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN PROCEDURE ON (B)(6). 2023 THE IDEAL SUTGRASPER 60 DEG DEVICE HOOK DID NOT RETURN TO ITS ORIGINAL POSITION AFTER THE SURGEON INSERTED THE DEVICE INTO THE ROTATOR CUFF, EXPOSED THE HOOK, AND RETRIEVED A SUTURE ADVANCING THE THUMB SLIDE. IT WAS REPORTED THAT THE SURGEON REMOVED THE DEVICE AS IT WAS AND OPERATED THE THUMB SLIDE, BUT THE HOOK STILL DID NOT RETURN TO ITS ORIGINAL POSITION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18229459 ↗
• MalfunctionOct 13, 2023Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON 10/4/23 THE IDEAL SUTGRASPER 60 DEG DEVICE TIPS WERE DAMAGED AND THE BROKEN FRAGMENTS REMAINED IN THE PATIENT'S BODY. IT WAS REPORTED THAT THERE WERE TWO BROKEN FRAGMENTS AND ONE OF THEM MAY BE A FRAGMENT OF THE TIP OF THE SUTURE GRASPER IN ADDITION TO THE FRAGMENT OF THE EDGE'S. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17931975 ↗
• MalfunctionAug 18, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE SHAFT ON THE 60° SUTURE GRASPER DEVICE WAS BENT AND ABOUT TO BREAK WHEN IT WAS TAKEN OUT OF THE JOINT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17573974 ↗
• MalfunctionJun 6, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2023, IT WAS OBSERVED THAT THE HOOK PART ON THE 60° SUTURE GRASPER DEVICE TO CATCH THE SUTURE WAS EXCESSIVELY BENT BACK FROM THE BEGINNING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHIN 30 MINUTES DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17073621 ↗
• MalfunctionApr 12, 2023Break; Break

  IT WAS REPORTED \BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT TIP ON THE 60° SUTURE GRASPER DEVICE BROKE OFF BUT WAS LATER FOUND THROUGH FLUOROSCOPY; AND WAS CONFIRMED BY X-RAY. ACCORDING TO THE REPORT, THE SUTURE GRASPER TIP CLIP STIFFNESS COULD NOT BE WITHSTOOD THE FRICTIONAL RESISTANCE OF THE LOADED ANCHOR AND THE TAPE. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED WITHIN 30 MINUTES DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16727313 ↗
• MalfunctionFeb 23, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING A ROTATOR CUFF REPAIR ON (B)(6) 2023, IT WAS OBSERVED THAT THE ANGLE OF THE 60° SUTURE GRASPER DEVICE WAS DIFFERENT FROM THE USUAL ONE. ACCORDING TO THE REPORT, THE SURGEON TRIED MANY TIMES TO CAPTURE A SUTURE, BUT THE SURGEON FAILED; AND COULD NOT CAPTURE A SUTURE. IT WAS REPORTED THAT THERE WAS A POSSIBILITY THAT THE ANGLE OF THE NITINOL HOOK WAS DISTORTED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHIN 30 MINUTES OF DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16431929 ↗
• MalfunctionJan 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN PROCEDURE ON 12/28/2022, IT WAS OBSERVED THAT THE 60° SUTURE GRASPER DEVICE CAME APART BEFORE USE. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16215707 ↗
• MalfunctionJan 16, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE 60° SUTURE GRASPER. DEVICE HAD COME OUT OF THE TIP OF THE NEEDLE WHEN THE DEVICE WAS OPENED. ACCORDING TO THE REPORT, THE SURGEON TRIED TO RETURN THE HOOK BACK INTO THE NEEDLE, BUT THE SURGEON COULD NOT DO IT BECAUSE THE THUMB SLIDE WAS VERY TIGHT AND THE DEVICE WAS UNABLE TO BE USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16174909 ↗
• MalfunctionNov 17, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE TIP ON THE SHAFT OF THE 60° SUTURE GRASPER DEVICE IMMEDIATELY BENT WHEN THE DEVICE WAS USED TO HANG A SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15815725 ↗
• MalfunctionJun 30, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE 60° SUTURE GRASPER DEVICE GOT CAUGHT IN SOFT TISSUE OR SOMETHING AND BROKE THE TIP. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14875947 ↗
• MalfunctionJun 15, 2022Material Deformation; Component Misassembled; Material Deformation; Component Misassembled

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE 60° SUTURE GRASPER WAS UNSEALED THAT THE HOOK ON THE NEEDLE HAD ALREADY COME OUT. ACCORDING TO THE REPORT, THEY TRIED TO RETRACT THE HOOK BACK INTO THE NEEDLE BUT FAILED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE WIRE HOOK SHAPE ON THE DEVICE WAS DEFORMED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14697181 ↗