EXPRESSEW 214157Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10886705025190), received between May 30, 2018 and Nov 19, 2024 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2024Device-Device Incompatibility; Noise, Audible; Device-Device Incompatibility; Noise, Audible

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WAS NOT FIRING PROPERLY, AND THE INSTRUMENT WAS MAKING A GRINDING NOISE WHEN FIRING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH LESS THAN FIVE MINUTES SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20723798 ↗
• MalfunctionNov 7, 2024Unintended Movement; Appropriate Device Problem Term/Code Not Available; Unintended Movement; Appropriate Device Problem Term/Code Not Available

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT THE DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE UPPER JAW ON THE DEVICE WAS LOOSE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20632234 ↗
• MalfunctionSep 5, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED BY SALES REP THAT DURING SHOULDER ARTHROSCOPY SURGICAL PROCEDURE IT WAS OBSERVED THAT THE EXPRESSEW III SUTURE PASSER W/ HOOK WAS BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE EXACT DATE OF THE EVENT WAS NOT REPORTED. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE DEVICE WAS LOOSE. 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 20150361 ↗
• MalfunctionJul 16, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE JAW ON THE EXPRESSSEW III AC GUN DEVICE WAS BENT, AND THE AUTO CAPTURE CLIP COULD NOT BE PUT ON. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. 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 19753774 ↗
• MalfunctionFeb 1, 2024Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING AN UNKNOWN SURGICAL PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE EXPRESSEW III AUTOCAPTURE FLEXIBLE SUTURE PASSER BROKE TO THE END OF THE CASE. 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 18627468 ↗
• MalfunctionAug 1, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY SALES REP THAT DURING ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT AN EXPRESSEW III NEEDLE DEVICE GOT STUCK THEN BROKE WHILE TRYING TO PASS THE SUTURE THRU EXPRESSEW III AUTOCAPTURE FLEXIBLE SUTURE PASSER DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE UPPER JAW ON THE DEVICE WAS BENT. 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 17436740 ↗
• MalfunctionJun 5, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE NEEDLE WAS BEING CAUGHT IN THE JAW ON THE EXPRESSEW III AUTOCAPTURE FLEXIBLE SUTURE PASSER DEVICE. 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 17064020 ↗
• MalfunctionJun 5, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE NEEDLE WAS BEING CAUGHT IN THE JAW ON THE EXPRESSEW III AUTOCAPTURE FLEXIBLE SUTURE PASSER DEVICE. 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 17059941 ↗
• MalfunctionMar 8, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE GRABBER AT THE END OF THE EXPRESSEW III AUTOCAPTURE FLEXIBLE SUTURE PASSER DEVICE SNAPPED WHILE GRABBING THE TISSUE. 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 16504958 ↗
• MalfunctionFeb 14, 2023Device-Device Incompatibility; Device-Device Incompatibility

  SUTURE IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE SUTURE KEPT GETTING STUCK IN THE LOWER JAW ON THE EXPRESSEW III AUTOCAPTURE FLEXIBLE SUTURE PASSER DEVICE WHEN TRYING TO PASS THROUGH TISSUE. 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 16371979 ↗
• MalfunctionJan 16, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE EXPRESSEW III AUTOCAPTURE FLEXIBLE SUTURE PASSER DEVICE WOULD NOT FULLY GRASP THE TENDON DUE TO THE TOP JAW BEING LOOSE. 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 16179301 ↗
• MalfunctionDec 6, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY SALES REP VIA EMAIL THAT DURING A ROTATOR CUFF REPAIR ON (B)(6) 2022, IT WAS OBSERVED THAT THE TOP JAW ON THE EXPRESSEW III AUTOCAPTURE FLEXIBLE SUTURE PASSER DEVICE WAS BENT ON. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH AN UNSPECIFIED MINOR DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15926591 ↗
• MalfunctionOct 12, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE EXPRESSEW III AUTOCAPTURE FLEXIBLE SUTURE PASSER WAS STICKING WHEN THE NEEDLE WAS FIRED. ACCORDING TO THE REPORT, IT APPEARED THAT THE JAWS MIGHT BE BENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A MINUTE OF DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15588872 ↗
• MalfunctionOct 7, 2022Material Deformation; Material Deformation

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE EXPRESSEW III AUTOCAPTURE FLEXIBLE SUTURE PASSER DEVICE WAS BENDING THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. 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 15563108 ↗
• MalfunctionMay 4, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER ARTHROSCOPY SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE EXPRESSEW III AUTOCAPTURE FLEXIBLE SUTURE PASSER DEVICE FAILED TO WORK. ACCORDING TO THE REPORT, THE PRONGS ON THE DEVICE WERE BENT THAT IT COULD NOT BE ATTACHED TO DISPOSABLE AUTOCAPTURE PLATE. 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 14279310 ↗
• MalfunctionDec 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY SALES REP THAT DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE SCREW ON THE EXPRESSSEW III AC GUN AT THE DISTAL TIP FELL OUT BUT WAS LATER RECOVERED FROM THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12975994 ↗
• MalfunctionFeb 11, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT TOP JAW ON THE EXPRESSSEW III AC GUN DEVICE WAS BROKEN AND WOULD NOT PASS THE SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11315923 ↗
• MalfunctionFeb 27, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN UNKNOWN PROCEDURE THE JAW OF THIS EXPRESSEW III AUTOCAPTURE FLEXIBLE SUTURE PASSER IS BENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9764689 ↗
• MalfunctionDec 17, 2019Positioning Failure; Positioning Failure

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE NEEDLE WAS CONSISTENTLY JAMMING IN THE EXPRESSSEW III AC GUN DEVICE. ACCORDING TO THE REPORT, THE NEEDLE JAMMED, REMOVED AND RETESTED; HOWEVER, IT CONTINUED TO JAM. IT WAS REPORTED THAT THE DEVICE JAMMED FOLLOWING SURGERY AS THE CASE STILL WENT AHEAD AS USUAL WITHOUT FURTHER DELAY. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THERE WAS DIFFICULTY FIRING THE NEEDLE FROM THE DEVICE AS THE NEEDLE SEEMED TO BE BINDING THAT IT DID NOT FIRE SMOOTHLY NOR RETRACT. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9481312 ↗
• MalfunctionOct 15, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED BY THE SALES REP THAT PRIOR TO AN UNKNOWN CASE DURING SETTING IT WAS FOUND BY THE SCRUB TECH THAT THE JAW ON THE CUSTOMER'S EXPRESSEW III AUTOCAPTURE FLEXIBLE SUTURE PASSER IS LOOSE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. THE DEVICE WILL BE RETURNING FOR EVALUATION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9193701 ↗
• MalfunctionSep 24, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, BUT BEFORE BEING USED ON THE PATIENT, THE SALES REP'S EXPRESSEW III AUTOCAPTURE FLEXIBLE SUTURE PASSER JAWS WOULD NOT CLOSE. THE CASE WAS COMPLETED WITH ANOTHER LIKE-DEVICE WITH NO PATIENT HARM OR DELAYS. THE SALES REP STATED THAT AFTER THE PROCEDURE WHILE INSPECTING THE DEVICE, HE MIGHT HAVE BROKEN THE NEEDLE INSIDE THE DEVICE. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9110673 ↗
• MalfunctionSep 16, 2019Positioning Failure; Positioning Failure

  IT WAS REPORTED BY THE SALES REP DURING A ROTATOR CUFF REPAIR, IT WAS OBSERVED THAT THE CUSTOMER'S EXPRESSEW III NEEDLE BECAME JAMMED INSIDE THEIR EXPRESSEW AUTOCAPTURE GUN WHEN DEPLOYED. THE SALES REP CONFIRMED NOTHING BROKE OFF WHILE IN THE PATIENT'S JOINT SPACE. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 9071220 ↗
• MalfunctionJan 24, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT THE TAB ON THE CUSTOMER'S EXPRESSEW NEEDLE FELL OFF CAUSING THE NEEDLE TO BE STUCK INSIDE OF THE EXPRESSEW III AUTOCAPTURE DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR DELAY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO 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 Consequences Or Impact To Patient

  MAUDE report 8274596 ↗
• MalfunctionJan 16, 2019Mechanical Jam; Mechanical Jam

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE SHOULDER, IT WAS OBSERVED THAT THE NEEDLE WOULD NOT GO BACK IN THEIR EXPRESSEW III AUTO CAPTURE; THEREFORE, THE SURGEON WAS UNABLE TO USE THE DEVICE. THE SALES REP STATED THAT WHEN USING A SECOND GUN THEIR EXPRESSEW III WITH HOOK AFTER FIRING THE DEVICE A COUPLE TIMES, THE GUN STOPPED WORKING. THE SALES REP STATED THAT THE NEEDLE SEEMED TO BE CATCHING ON SOMETHING AND NO LONGER FIRING. THE SALES REP STATED THAT THEY EVEN CHANGED OUT THE NEEDLE TO ANOTHER ONE AND THE SAME ISSUE STILL OCCURRED. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH AN ARTHREX'S DEVICE WITH NO PATIENT CONSEQUENCES BUT THERE WAS A TWO MINUTE DELAY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO 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 Consequences Or Impact To Patient

  MAUDE report 8254382 ↗
• MalfunctionJan 14, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP VIA CST THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE EXPRESSEW III AUTOCAPTURE WAS DROPPED AND BENT THE BOTTOM JAW OF THE DEVICE. THE SALES REP STATED THAT DUE TO THIS, THE SUTURE WOULD NOT PASS THROUGH TO ENGAGE WITH THE NEEDLE. THE CASE WAS COMPLETED WITH ANOTHER LIKE-DEVICE WITH NO PATIENT HARM OR DELAY. THE DEVICE IS BEING RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8243979 ↗