EXPRESSEW 288234Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10886705027118), received between Mar 29, 2018 and Nov 4, 2025 — classified as 6 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (17 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT WHEN MOUNTING THE ITEM WITH A CLAMP AND THE EXPRSEW III AC+ RTN PLATE 5PK DEVICE IT WAS VERIFIED THAT THE INNER BLADE WAS CROOKED SO THE CLAMP DID NOT FIT INTO THE PLATE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23468595 ↗
• MalfunctionJun 25, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A VERTICAL SURGICAL PROCEDURE; WHILE USING THE PLATE OF THE EXPRSEW III DEVICE, IT DID NOT FIT INTO THE CLAMP. THE USER ATTEMPTED ALL WAYS BUT IT DID NOT FIT. THE USER IDENTIFIED THAT THE PLATE WAS FACING UP, AND WITH THAT THE CLAMP DID NOT CONNECT. THERE WERE NO REPORTS OF DELAY IN THE PROCEDURE 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 22330869 ↗
• MalfunctionApr 24, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT WHEN OPENING THE EXPRSEW III AC+ RTN PLATE/LOADING TOOL, THE SCRUB TECH PROCEEDED TO REMOVE THE CARDBOARD THAT COMES LOADED ON THE PLATE AND CARRIAGE. THE CARDBOARD WAS STUCK INSIDE OF THE CARRIAGE, SO SURGEON WAS NOT ABLE TO REMOVE THE FULL PIECE AT ONCE LIKE IT DOES NORMALLY. TO REMOVE THE REST OF THE CARDBOARD, THE SURGEON USED A HEMOSTAT TO PULL THE REMAINING CARDBOARD BUT WAS ABLE TO REMOVE IT FROM THE CARRIAGE SUCCESSFULLY. FROM THERE, SURGEON WENT TO LOAD THE PRODUCT ON THE EXPRESSEW AUTOCAPTURE + GUN. WHEN SURGEON WENT TO PUSH THE GUN INTO THE CARRIAGE TO LOAD THE PLATE, THE TWO PLASTIC PIECES COMBINING TO FORM THE CARRIAGE BROKE APART, MAKING THE PRODUCT UNUSABLE. ANOTHER 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 21902267 ↗
• MalfunctionMar 10, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON SHOULDER, THE EXPRSEW III AC+ RTN PLATE DEVICE WAS BEING USED FOR THREADING THE INNER ANCHOR. BECAUSE THE RETENTION PLATE COULD NOT GRASP, THE NEEDLE WAS USED AND THEN THE GRASPER WAS USED TO TAKE THE SUTURE. WHEN CHECKED, THE TIP OF THE PLATE WAS SLIGHTLY CURVED, SO IT WAS REPLACED WITH A NEW ONE. THE PROBLEM WAS THEN RESOLVED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558835 ↗
• MalfunctionFeb 25, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE EXPRSEW III AC+ RTN PLATE 5PK DEVICE AUTO CAPTURE PLATE FAILED TO LOAD ON EXPRESSEW DURING THE SHOULDER SCOPE. ALL STEPS WERE FOLLOWED CORRECTLY BUT THE PLATE WAS UNABLE TO BE LOADED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECT TO THE PATIENT AND DID NOT SIGNIFICANTLY INCREASE CASE TIME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21460859 ↗
• MalfunctionFeb 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE RETENTION PLATE ON THE DEVICE WAS LEFT BEHIND IN THE PATIENT. UPON FOLLOW UP, THE DR WAS EVALUATING X-RAYS AND NOTICED THE FOREIGN BODY. UPON FURTHER INVESTIGATION, THEY DETERMINED IT WAS THE AUTO CAPTURE RETENTION PLATE THAT WAS THE FOREIGN BODY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. THE EXACT DATE OF THE EVENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21355568 ↗
• MalfunctionOct 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, AN EXPRSEW III AC+ RTN PLATE DEVICE WAS USED. ACCORDING TO THE REPORT, THE EXPRESSEW FLAP DISENGAGED FROM THE JAW OF THE EXPRESSEW FORCEPS AND ENDED UP IN THE PATIENT'S SHOULDER. IT WAS REPORTED THAT THE SURGEON HAD TO USE THE X-RAY TO FIND THE FLAP AND EXTRACT IT. THERE WAS PATIENT INVOLVEMENT. THERE WAS AN UNSPECIFIED DELAY IN THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397515 ↗
• MalfunctionApr 4, 2024Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE EXPRESSEW III AUTOCAPTURE + RETENTION PLATE/LOADING TOOL-5 PACK HAD A DEFECTIVE PLATE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE PLATE WAS ALREADY OUT OF THE LOADING TOOL. THERE WAS AN UNSPECIFIED DELAY IN THE PROCEDURE WHILE LOOKING FOR THE FIRST PLATE TO MAKE SURE IT WAS NOT IN THE PATIENT. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 19041929 ↗
• MalfunctionMar 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP IN AUSTRALIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 THE EXPRSEW III AC+ RTN PLATE 5PK DEVICE AUTO CAPTURE PLATE FELL OFF AND INTO THE PATIENT. THERE WAS A FIFTEEN MINUTE DELAY TO THE PROCEDURE. IT WAS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ALL FRAGMENTS WERE REMOVED. 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 18973246 ↗
• MalfunctionFeb 28, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2024, THE EXPRSEW III AC+ RTN PLATE DEVICE WOULD NOT LOAD ON GUN DESPITE PROPER PROCEDURE BEING FOLLOWED. THERE WAS A THREE MINUTE DELAY IN THE SURGICAL PROCEDURE. 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 18797813 ↗
• MalfunctionAug 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE PLATE ON THE EXPRESSEW III AUTOCAPTURE + RETENTION PLATE/LOADING TOOL-5 PACK DEVICE CAME OFF WHILE SHOOTING. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITHOUT USING AUTOCAPTURE. 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 17500886 ↗
• InjuryAug 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN SWITZERLAND THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON AN UNKNOWN DATE, EXPRESSEW III NEEDLE AND EXPRESSEW III AUTOCAPTURE + RETENTION PLATE/LOADING TOOL-5 PACK DEVICES WERE USED. ACCORDING TO THE REPORT, THE RETENTION PLATE WAS DETECTED POSTOPERATIVELY THROUGH X-RAY; AND REMAINED IN THE SHOULDER. IT WAS FURTHER REPORTED THAT AN ADDITIONAL PROCEDURE HAS BEEN SCHEDULED FOR THE REMOVAL OF THE FOREIGN BODY. THE STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 17483209 ↗
• MalfunctionMay 4, 2023Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  THIS IS REPORT 2 OF 8 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE EXPRESSEW III AUTOCAPTURE + RETENTION PLATE/LOADING TOOL-5 PACK DEVICE WOULD NOT CAPTURE THE DYNATAPE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH OVER AN HOUR DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16872122 ↗
• MalfunctionMay 4, 2023Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  THIS IS REPORT 1 OF 8 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE EXPRESSEW III AUTOCAPTURE + RETENTION PLATE/LOADING TOOL-5 PACK DEVICE WOULD NOT CAPTURE THE DYNATAPE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH OVER AN HOUR DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16871786 ↗
• MalfunctionMay 4, 2023Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  THIS IS REPORT 4 OF 4 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT FOUR EXPRESSEW III AUTOCAPTURE + RETENTION PLATE/LOADING TOOL-5 PACK WOULD NOT CAPTURE THE SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH OVER AN HOUR DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16871660 ↗
• MalfunctionMay 4, 2023Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  THIS IS REPORT 3 OF 4 FOR(B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT FOUR EXPRESSEW III AUTOCAPTURE + RETENTION PLATE/LOADING TOOL-5 PACK WOULD NOT CAPTURE THE SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH OVER AN HOUR DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16871650 ↗
• InjuryMar 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE PLATE ON THE EXPRSEW III AC+ RTN PLATE DEVICE WAS DISCONNECTED OF THE GUN AND GOT LOST IN THE PATIENT THAT IT COULD NOT BE RETRIEVED. THE PATIENT WAS REPORTED TO BE CURRENTLY IN STABLE CONDITION; AND THAT THE DEVICE WAS OUTSIDE THE SHOULDER JOINT. THERE WAS A SURGICAL DELAY OF 45 MINUTES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13711581 ↗
• InjuryMar 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A SHOULDER REPAIR PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE RETENTION PLATE ON THE EXPRSEW III AC+ RTN PLATE DEVICE WAS NOT REMOVED AFTER THE END OF THE SURGERY. ACCORDING TO THE REPORT, A SECOND PLATE WAS PUT ON TOP FOR A NEW SURGERY AS THE PLATE FELL INSIDE THE PATIENT. IT WAS REPORTED THAT ALTHOUGH FRAGMENTS WERE GENERATED AND WERE NOT REMOVED, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS REPORTED THAT AN X-RAY WAS PERFORMED AFTER THE SURGERY ON THE PATIENT. IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED TO HAVE A SECOND SURGERY TO REMOVE THE PLATE. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13660235 ↗
• InjuryMar 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A SHOULDER REPAIR PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE RETENTION PLATE ON THE EXPRSEW III AC+ RTN PLATE DEVICE WAS NOT REMOVED AFTER THE END OF THE SURGERY. ACCORDING TO THE REPORT, A SECOND PLATE WAS PUT ON TOP FOR A NEW SURGERY AS THE PLATE FELL INSIDE THE PATIENT. IT WAS REPORTED THAT ALTHOUGH FRAGMENTS WERE GENERATED AND WERE NOT REMOVED, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS REPORTED THAT AN X-RAY WAS PERFORMED AFTER THE SURGERY ON THE PATIENT. IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED TO HAVE A SECOND SURGERY TO REMOVE THE PLATE. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13660232 ↗
• MalfunctionOct 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE PLATE ON THE EXPRSEW III AC+ RTN PLATE DEVICE FELL OFF. 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 12577995 ↗
• MalfunctionJul 13, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE RETENTION PLATE ON THE EXPRSEW III AC+ RTN PLATE DID NOT CONNECT WITH THE TOP JAW THAT THE PLATE WAS FOUND INSIDE THE INSERTION CHAMBER. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF ONE MINUTE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12159168 ↗
• MalfunctionSep 17, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED VIA COMPLAINT SUBMISSION TOOL THAT DURING AN UNKNOWN PROCEDURE, WHILE ATTEMPTING TO LOAD THE EXPRESSEW III AUTOCAPTURE + RETENTION PLATE/LOADING TOOL-5 PACK, IT FAILED TO LOAD SECURELY ONTO THE GUN. THE PLATE BECAME LOOSE AND WAS RETRIEVED AND DISPOSED OF. A NEW PLATE WAS OPENED AND LOADED WITHOUT CONCERN AND THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF 3 MINUTES. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: Not Applicable

  MAUDE report 10550494 ↗
• MalfunctionAug 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA COMPLAINT SUBMISSION TOOL THAT DURING AN UNKNOWN PROCEDURE, WHILE USING AN EXPRESSEW III AUTOCAPTURE + RETENTION PLATE/LOADING TOOL-5 PACK, THE RETENTION PLATE WAS LOADED PROPERLY AND PRE-USE CHECK WAS DONE. HOWEVER, RETENTION PLATE DISLODGED FROM EXPRESSEW INSTRUMENT DURING USAGE. SURGEON WAS ABLE TO SIGHT IT ARTHROSCOPICALLY DURING SURGERY, REMOVED IT AND DISCARDED IT. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION REPORTED FROM THE AFFILIATE STATED THE EVENT OCCURRED DURING A SUPRASPINATUS ROTATOR CUFF REPAIR AND THE PROCEDURE WAS COMPLETED BY AUTOCAPTURE BOARD WAS RETRIEVED. A NEW AUTOCAPTURE BOARD WAS RELOADED ONTO THE EXPRESSEW INSTRUMENT. IT WAS ALSO REPORTED THAT A SURGICAL DELAY OF 1 HOUR OCCURRED BUT THERE WAS NO KNOWN PATIENT CONSEQUENCES DUE TO THIS DELAY.

  Patient problems: Not Applicable

  MAUDE report 10439629 ↗
• MalfunctionJun 23, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY SALES REP VIA COMPLAINT SUBMISSION TOOL THAT DURING A ROTATOR CUFF REPAIR, WHILE USING AN EXPRESSEW III AUTOCAPTURE + RETENTION PLATE/LOADING TOOL-5 PACK, THE RETENTION PLATE WOULD NOT LOAD INTO DEVICE. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY OPENING A NEW RETENTION PLATE. IT WAS ALSO REPORTED THERE WAS A MINOR SURGICAL DELAY OF ONE MINUTE WHICH CAUSED BY RETRIEVING A NEW DEVICE TO USE. THE AFFILIATE REPORTED THERE WERE NO KNOWN PATIENT CONSEQUENCES.

  Patient problems: Not Applicable

  MAUDE report 10185155 ↗
• MalfunctionMar 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE THE JAW OF THE EXPRESSEW III AUTOCAPTURE + RETENTION PLATE/LOADING TOOL CAME OFF FROM THE EXPRESSEW GUN. ANOTHER RETENTION PLATE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. TRUNK STOCK ADJUSTMENT REQUESTED. NO REPLACEMENT NEEDED. THE DEVICE WAS DISCARDED BY THE FACILITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9835697 ↗