EXPRESSEW 288235Recalls & reported problems

Summary

The FDA's MAUDE database contains 151 adverse event reports that list this exact device (DI 10886705027125), received between Jun 5, 2018 and Sep 15, 2026 — classified as 9 injuries, 142 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (116 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 151 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779851 ↗
• MalfunctionSep 14, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50763279 ↗
• MalfunctionSep 10, 2026Device-Device Incompatibility; Material Deformation

  It was reported that during an unknown surgery, when performing the first suturing step in tissue with the EXPRSEW III AC+ RTN PLATE device, the plate did not properly hold the suture. A second attempt was made and the plate released the thread. On inspection, the plate tip was slightly raised and therefore did not retain the thread. The specialist used another retaining plate, which worked properly. There were no delays to the surgical procedure. 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 50718037 ↗
• MalfunctionJun 24, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE, THE EXPRSEW III AC+ RTN PLATE 1EA COULD NOT BE ATTACHED TO AUTOCAPUTURE EVEN THOUGH IT WAS USED IN A NORMAL WAY. THE SURGERY WAS COMPLETED WITH NO ISSUES USING NEW IMPLANT. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25615640 ↗
• MalfunctionJun 23, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR, THE EXPRESS CAME OFF THE MAIN UNIT. THE SURGERY WAS COMPLETED WITH NO ISSUES USING ANOTHER PRODUCT. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25598212 ↗
• MalfunctionJun 17, 2026Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE EXPRSEW III AC+ RTN PLATE DEVICE THE PLATE WOULD NOT FIX TO THE INSTRUMENT AND BECAME STUCK. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 5 MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25538116 ↗
• MalfunctionJun 16, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A SHOULDER GREATER TUBERCLE FRACTURE REPAIR PROCEDURE THE EXPRSEW III AC+ RTN PLATE DEVICE COULD NOT BE ATTACHED AND COME OFF EVEN THOUGH IT WAS PERFORMED CORRECTLY . ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25523785 ↗
• MalfunctionMay 26, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE EXPRSEW III AC+ RTN PLATE DEVICE SURGEON WAS UNABLE TO ASSEMBLE THE PLATE TO THE DEPLOYMENT GUN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25285968 ↗
• MalfunctionMay 11, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, THE RETENTION PLATE OF THE EXPRESSEW COULD NOT BE CONNECTED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE PRODUCT WAS DISCARDED. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137698 ↗
• MalfunctionApr 21, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE EXPRSEW III AC+ RTN PLATE 1EA DEVICE SUDDENLY DETACHED FROM THE MAIN UNIT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO REMNANTS FOUND INSIDE THE PATIENT¿S BODY. THERE WAS NO 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 24948365 ↗
• MalfunctionApr 21, 2026Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGERY, WHEN CONNECTING THE EXPRSEW III AC+ RTN PLATE DEVICE TO THE AUTO-CAPTURE DEVICE, IT FAILED TO CONNECT AND FELL INTO THE WHITE CASE. THE OPERATION WAS SUCCESSFULLY COMPLETED USING A NEW DEVICE. THERE WERE NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24938486 ↗
• MalfunctionMar 19, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR FOR ROTATOR CUFF TEAR THAT THE EXPRSEW III AC+ RTN PLATE DEVICE DIDN'T WORK PROPERLY. UPON CHECKING THE TIP, IT WAS FOUND THAT THE RETENTION PLATE HAD DEFORMED, MAKING IT UNABLE TO CATCH THE TAPE. AFTER SEVERAL ATTEMPTS, IT FAILED TO CATCH THE TAPE, SO ANOTHER PRODUCT WAS USED, AND THE OPERATION WAS COMPLETED WITHOUT PROBLEMS. THERE WAS A 30 MIN. DELAY IN THE PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24642875 ↗
• MalfunctionMar 17, 2026Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE, WHEN PREPARING THE EXPRSEW III AC+ RTN PLATE AUTO CAPTURE DEVICE THE RETENTION PLATE DID NOT CONNECT TO THE MAIN UNIT. THE SURGEON TRIED AGAIN, BUT IT DID NOT CONNECT AND THE PLATE FELL INTO THE CASE. IT WAS REPORTED THAT THE SURGEON CONNECTED A NEW ONE AND THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621637 ↗
• MalfunctionMar 17, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE EXPRSEW III AC+ RTN PLATE DEVICE WAS NOT ATTACHED PROPERLY AND COULD NOT BE USED. IT WAS REPORTED THAT THE SURGEON USED THE DEVICE AS USUAL. IT WAS REPORTED THAT THE SURGEON USED ANOTHER SIMILAR DEVICE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, OR SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617500 ↗
• MalfunctionJan 27, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE, THE EXPRSEW III AC+ RTN PLATE DEVICE WHILE SETTING UP THE AUTO CAPTURE, A PLATE WAS LEFT INSIDE THE WHITE CASE, CAUSING A POOR CONNECTION. A DIFFERENT PLATE WAS CONNECTED, AND THE OPERATION WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. ANOTHER 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. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24190847 ↗
• MalfunctionJan 7, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE FOR ROTATOR CUFF TEAR, THE SURGEON ATTEMPTED TO PERFORM A ROTATOR CUFF SUTURE USING THE AUTOCAPTURE PASSER DEVICE BUT EXPERIENCED SOME DISCOMFORT WITH THE DEVICE¿S OPERATION. IT WAS REPORTED THAT THE NEEDLE WAS USABLE WITHOUT ISSUE, BUT THE EXPRSEW III AC+ RTN PLATE RETENTION PLATE WAS REPLACED. IT WAS REPORTED THAT ANOTHER PRODUCT WAS RELOADED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON THOUGHT THAT THERE MIGHT BE A PROBLEM WITH THE MAIN UNIT, SO THE OPERATION OF THE UNIT WAS CHECKED AFTER THE SURGERY, BUT NO PROBLEMS WERE FOUND. THERE WAS A 30-MINUTE SURGICAL DELAY DUE TO THE EVENT. THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23990304 ↗
• MalfunctionJan 7, 2026Detachment of Device or Device Component; Unintended Movement

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR SURGICAL PROCEDURE, THE EXPRSEW III AC+ RTN PLATE DEVICE, WHEN USING AUTOCAPTURE WITH A WAYOLAX INSERTED, THE RETENTION PLATE BECAME LOOSE AND CAME OFF OUTSIDE THE BODY. A NEW PLATE WAS USED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23988720 ↗
• MalfunctionJan 6, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE, THE SURGEON ATTEMPTED TO SET UP THE EXPRSEW III AC+ RTN PLATE DEVICE TO USE THE EXPRESSES AUTOCAPTURE DEVICE TO APPLY SUTURES TO THE ROTATOR CUFF TEAR BUT WAS UNABLE TO LOAD IT PROPERLY. THEREFORE, A NEW RETENTION PLATE WAS USED, AND IT COULD BE SET WITHOUT ANY PROBLEMS. THE SURGEON INSERTED AN ANCHOR, APPLIED SUTURES TO THE ROTATOR CUFF, AND PERFORMED A BRIDGE PROCEDURE. THERE WAS NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23976441 ↗
• MalfunctionDec 30, 2025Device-Device Incompatibility; Device-Device Incompatibility

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, AN EXPRSEW III AC+ RTN PLATE DEVICE FAILED TO LOAD AND REMAINED IN ITS PLASTIC LOADER, AND A SECOND PLATE ALSO FAILED TO LOAD. THERE WAS FIVE-MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. 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 23921306 ↗
• MalfunctionDec 30, 2025Device-Device Incompatibility; Device-Device Incompatibility

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, AN EXPRSEW III AC+ RTN PLATE DEVICE FAILED TO LOAD AND REMAINED IN ITS PLASTIC LOADER, AND A SECOND PLATE ALSO FAILED TO LOAD. THERE WAS FIVE-MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. 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 23921295 ↗
• MalfunctionDec 24, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE EXPRSEW III DEVICE, THE SURGEON OPERATED THE PLATE AS PER THE PROCEDURE MANUAL, BUT THE PLATE COULD NOT BE LOADED INTO THE INSTRUMENT. 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888481 ↗
• MalfunctionDec 16, 2025Break; Unintended Movement; Break; Unintended Movement

  IT WAS REPORTED THAT THE EXPRSEW III AC+ RTN PLATE DEVICE IS BROKEN AND LOOSE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815328 ↗
• MalfunctionDec 9, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THIS WAS AN ARTHROSCOPIC ROTATOR CUFF REPAIR ON SHOULDER JOINT FOR ROTATOR CUFF TEAR PERFORMED. AFTER OPENING THE PLATE, AN ATTEMPT WAS MADE TO INSERT AND THEN REMOVE IT FROM THE MAIN BODY, BUT THE PLATE COULD NOT BE LOADED. AFTER SEVERAL ATTEMPTS, THE PLATE COULD NOT LOAD. ANOTHER PRODUCT WAS USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS 30 MINUTES 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 23761099 ↗
• MalfunctionNov 20, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE EXPRSEW III DEVICE, THE AUTOCAPTURE LOADER WAS APPLIED TO THE EXPRESSEW GUN DEVICE AS NORMAL AND WHEN IT WAS PULLED OFF THE PLATE HAD NOT LOADED. A SECOND PLATE WAS OPENED AND APPLIED IN THE SAME WAY IT LOADED WITHOUT ISSUE. THERE WAS NO 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 23606361 ↗
• MalfunctionNov 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE, DESPITE THE SURGEON PROPERLY LOADING THE EXPRSEW III AC RETENTION PLATE INTO THE AUTOCAPTURE DEVICE, THE RETENTION PLATE CAME OFF. IT WAS REPORTED THAT A NEW RETENTION PLATE WAS USED AND LOADED INTO THE AUTOCAPTURE WITHOUT ANY PROBLEMS. THERE WERE NO SURGICAL DELAYS AND NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23553610 ↗