NA 214.140Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10886982153821), received between Feb 12, 2018 and Jan 25, 2019 — classified as 31 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 25, 2019Difficult to Open or Close; Physical Resistance/Sticking; Difficult to Open or Close; Physical Resistance/Sticking

  IT WAS REPORTED BY THE SALES REP IN THAT THE JAW ON THE CUSTOMER'S EXPRESSEW III WITHOUT HOOK LOCKED WHILE PARTIALLY CLOSED WHEN FIRING THE NEEDLE DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. THE SALES REP WAS NOT PRESENT DURING THE CASE AND COULD NOT PROVIDE ANY MORE DETAILS. THE DEVICE IS BEING RETURNED. 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 8278361 ↗
• MalfunctionJan 25, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT HE SPRING ON THE CUSTOMER'S EXPRESSEW III WITHOUT HOOK BROKE DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE. THE SALES REP STATED THAT THE DEVICE BROKE OUTSIDE OF THE PATIENT. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP WAS NOT PRESENT DURING THE CASE AND COULD NOT PROVIDE ANY MORE DETAILS. 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 8277604 ↗
• MalfunctionJan 25, 2019Mechanical Jam; Mechanical Jam

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER'S EXPRESSEW III NEEDLE BECAME JAMMED INSIDE THEIR EXPRESSEW III WITHOUT HOOK DURING A SHOULDER SCOPE SURGICAL PROCEDURE. THE CASE WAS COMPLETED WITH OTHER LIKE DEVICES. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP WAS NOT PRESENT DURING THE CASE AND COULD NOT PROVIDE ANY MORE DETAILS. 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 8276943 ↗
• MalfunctionJan 23, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP THAT THE NEEDLE WAS STUCK IN THE GUN ON THE CUSTOMER'S EXPRESSEW III WITHOUT HOOK POST A ROTATOR CUFF SURGICAL PROCEDURE. THE CASE WAS ABLE TO BE COMPLETED WITH THE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR TIME 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 8271585 ↗
• MalfunctionJan 23, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER'S EXPRESSEW III WITHOUT HOOK FAILED DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE DUE TO THE NEEDLE JAMMING WHILE IN USE. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR TIME DELAYS. 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 8270475 ↗
• MalfunctionJan 23, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER'S EXPRESSEW III WITHOUT HOOK FAILED DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE. ACCORDING TO THE REPORTER, THE DEVICE DID NOT WORK WHEN PULLING TRIGGER ON THE DEVICE. IT WAS REPORTED THAT A PIECE WAS FLOPPING ON THE TRIGGER AND THEN IT BROKE. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR TIME DELAY. THE REP WAS NOT PRESENT FOR THE CASE. THE DEVICE WILL BE RETURNED FOR EVALUATION AS IT IS NOT UNDER WARRANTY. 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 8270389 ↗
• MalfunctionJan 22, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER'S EXPRESSEW III WITHOUT HOOK MISFIRED REPEATEDLY DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE. ACCORDING TO THE REPORTER, SOMETHING WAS BROKE IN THE DEVICE CAUSING THE NEEDLE TO BREAK. THE SALES REP STATED THAT THE DEVICE DID NOT BREAK IN THE PATIENT. THE CASE WAS COMPLETED WITH A COMPETITOR PRODUCT. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE DEVICE WILL BE RETURNED FOR EVALUATION. THE SALES REP WAS NOT PRESENT FOR THE CASE AND COULD NOT PROVIDE ANY MORE DETAILS. 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 8267902 ↗
• MalfunctionJan 22, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER'S EXPRESSEW III WITHOUT HOOK DIDN'T WORK ON A ROTATOR CUFF SURGICAL PROCEDURE DUE TO THE NEEDLE NOT PASSING CORRECTLY THROUGH THE TISSUE AND STICKING WHILE TRYING TO PASS THROUGH THE ROTATOR CUFF. THE SALES REP WAS PRESENT FOR THE CASE AND REPORTED THAT THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE DEVICE IS BEING RETURNED FOR EVALUATION. 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 8267838 ↗
• MalfunctionJan 22, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF PROCEDURE, THE PIN THAT CONTROLS THE JAW ON THE CUSTOMER'S EXPRESSEW III WITHOUT HOOK BROKE. THE SALES REP CONFIRMED THAT NOTHING FELL IN THE PATIENT AND THAT THE ISSUE OCCURRED PRIOR TO USE ON THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES BUT THERE WAS A FIVE MINUTE DELAY TO GRAB THE OTHER DEVICE. THE DEVICE WILL BE RETURNING FOR EVALUATION. 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 8266505 ↗
• MalfunctionOct 31, 2018Material Twisted/Bent; Material Twisted/Bent

  THE SALES REPRESENTATIVE REPORTED THAT DURING A ROTATOR CUFF REPAIR THAT THE CUSTOMER'S EXPRESSEW III WITHOUT HOOK WAS NOT FIRING THE NEEDLE CORRECTLY. THE SALES REPRESENTATIVE REPORTED THAT THE END OF THE DEVICE WAS SLIGHTLY BENT. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES. THERE WAS A TEN (10) MINUTE DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8023647 ↗
• MalfunctionOct 26, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED THAT DURING A ROTATOR CUFF PROCEDURE THE ESPRESSEW NEEDLE BROKE WITHIN THE TIP OF THE CUSTOMER'S EXPRESSEW III WITHOUT HOOK THE FIRST TIME THE DEVICE WAS FIRED. THE SALES REPRESENTATIVE STATED THAT WHEN REMOVING THE NEEDLE FROM THE DEVICE AND THE BROKEN PIECE WAS STILL STUCK AT THE TIP OF THE DEVICE AND IS UNABLE TO USE THE DEVICE. THE SALES REPRESENTATIVE REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REPRESENTATIVE STATED THAT NOTHING BROKE IN THE PATIENT. THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8009039 ↗
• MalfunctionOct 4, 2018Break; Break

  IT WAS REPORTED DURING A ROTATOR CUFF PROCEDURE, A NEEDLE BROKE. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION FROM THE AFFILIATE: THE EXPRESSEW III GUN WOULD NOT FIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7933822 ↗
• MalfunctionSep 18, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF PROCEDURE, IT WAS OBSERVED THAT THE HANDLE MECHANISM THAT OPENS AND CLOSES THE JAW ON THE CUSTOMER'S EXPRESSEW III WITHOUT HOOK BROKE OFF. THE SALES REP STATED THAT WHERE THE DEVICE BROKE WAS OUTSIDE THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. 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 7884809 ↗
• MalfunctionSep 14, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT PRIOR TO A ROTATOR CUFF REPAIR, THE SURGEON NOTICED THE TOP JAW ON THE CUSTOMER'S EXPRESSEW III W/O HOOK WAS BROKEN. IT WAS IMMEDIATELY SWAPPED OUT FOR ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. 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 7876083 ↗
• MalfunctionSep 12, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR, IT WAS OBSERVED THAT THE JAWS ON THE CUSTOMER'S EXPRESSEW III WITHOUT HOOK WAS BENT AND NOT FIRING PROPERLY. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP HAD NO FURTHER INFORMATION REGARDING HOW THE DEVICE WAS FIRING. 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 7868539 ↗
• MalfunctionSep 11, 2018Mechanical Jam; Mechanical Jam

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR, IT WAS OBSERVED THAT THE NEEDLE BROKE INSIDE THE EXPRESSEW III WITHOUT HOOK. THE SALES REP REPORTED THAT THE NEEDLE BROKE AT THE PROXIMAL END NEAREST THE SURGEON HAND AND REMAINED JAMMED INSIDE THE GUN. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAY. THE SALES REP WAS NOT PRESENT AND DID NOT KNOW IF THE NEEDLE BROKE WHILE BEING LOADED OR FIRED. IT WAS FURTHER REPORTED THAT AFTER DISCUSSING THE COMPLAINT WITH THE SCRUB TECH WORKING, IT TURNS OUT THEY LOADED THE NEEDLE INTO THE DEVICE INCORRECTLY. THEY HAVE BEEN EDUCATED ON HOW/WHERE TO LOAD THE DEVICE AND IT HAS BEEN WORKING PROPERLY. 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 7863744 ↗
• MalfunctionSep 6, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT POST TO AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND DURING CLEANING THE SPRING WITHIN THEIR EXPRESSEW III WITHOUT HOOK BROKE AND THAT THE BOTTOM JAW WAS NOT ALIGNING WITH THE TOP JAW WHEN CLOSING. THE SALES REP REPORTED THAT THE SURGEON HAD COMPLETED THE PROCEDURE WITH THE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. 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 7850207 ↗
• MalfunctionAug 24, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE JAW'S ON THE CUSTOMER'S EXPRESSEW III WITHOUT HOOK WERE BENT AND THEIR CORD CUTTER WAS NOT CUTTING SUTURES DURING A ROTATOR CUFF PROCEDURE. THE SURGEON USED TWO DIFFERENT DEVICES TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAYS. NO FURTHER DETAILS WERE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7813381 ↗
• MalfunctionAug 15, 2018Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT POST TO A ROTATOR CUFF REPAIR PROCEDURE THE CUSTOMER'S EXPRESSEW III NEEDLE IS JAMMED IN THE EXPRESSEW III WITHOUT HOOK. THE PROCEDURE HAD ALREADY BEEN COMPLETED WITH THE DEVICE BEFORE THE ISSUE OCCURRED, AND THERE WAS NO PATIENT HARM OR DELAYS TO THE CASE. THE SALES REP WAS NOT PRESENT FOR THE CASE AND COULD NOT PROVIDE ANY ADDITIONAL INFORMATION, OR A LOT FOR THE EXPRESSEW III NEEDLE. THE DEVICE IS BEING RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7784671 ↗
• MalfunctionJul 26, 2018Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE JAW OF THEIR EXPRESSEW III WITHOUT HOOK IS BENT AND LOOSE CAUSING THE NEEDLE TO NOT FIRE PROPERLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXPRESSEW WITH NO HARM TO THE PATIENT OR DELAYS TO THE CASE. THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7724193 ↗
• MalfunctionJul 9, 2018Fracture; Mechanical Jam; Fracture; Mechanical Jam

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE EXPRESSEW III W/O HOOK DEVICE DID NOT WORK. ACCORDING TO THE REPORT, THE EVENT OCCURRED DUE TO THE NEEDLE BREAKING OFF INSIDE THE GUN AND JAMMING INSIDE. IT WAS REPORTED THAT THE NEEDLE REMAINED IN THE GUN AND NEVER INSIDE PATIENT. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH A SPARE DEVICE. THERE WAS PATIENT INVOLVEMENT. 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 7670297 ↗
• MalfunctionJun 28, 2018Bent; Material Twisted/Bent; Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE BOTTOM JAW ON THE CUSTOMER'S EXPRESSEW III WITHOUT HOOK IS NOT A LINING WITH THE TOP JAW THEREFORE THE NEEDLE IS OFF CENTER WHEN FIRED. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE DEVICE WITH NO HARM TO THE PATIENT OR DELAYS TO THE CASE. THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7646342 ↗
• MalfunctionMay 7, 2018Failure to Advance; Failure to Advance

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF PROCEDURE THE NEEDLE GOT JAMMED INSIDE OF THE EXPRESSEW III WITHOUT HOOK AND THEY WERE UNABLE TO REMOVE IT FROM THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO HARM TO THE PATIENT OR DELAYS TO THE CASE. THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7492216 ↗
• MalfunctionMay 4, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE JAW ON THE CUSTOMER'S EXPRESSEW BROKE OFF OF THE DEVICE WHILE INSPECTING IT ON THE BACK TABLE DURING A SHOULDER SCOPE. THE SALES REP ALSO STATED THAT TWO EXPRESSEW III NEEDLES BECAME STUCK IN THE GUN DUE TO THE CLEAR TAB ON THE NEEDLE COMING OFF. THE CASE WAS COMPLETED WITH ANOTHER EXPRESSEW III GUN AND A DIFFERENT LOT OF EXPRESSEW III NEEDLES. THERE WERE NO PATIENT CONSEQUENCES BUT A 2 MINUTE DELAY WAS REPORTED TO SWITCH OUT THE DEVICES. NO PARTS OF THE EXPRESSEW III GUN FELL INTO THE PATIENT. THE EXPRESSEW III NEEDLES WERE DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7489193 ↗
• MalfunctionMay 1, 2018Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER PROCEDURE THEIR EXPRESSEW III NEEDLE BROKE IN THEIR EXPRESSEW III WITHOUT HOOK. THE GUN WAS FIRED APPROXIMATELY SIX TIMES BEFORE THE NEEDLE BROKE. ORTHOCORD WAS USED FOR SUTURE DURING THE CASE. THE PROCEDURE WAS COMPLETED WITH ANOTHER GUN AND NEEDLE WITH NO HARM TO THE PATIENT BUT THERE WAS A MINUTE DELAY TO GRAB OTHER LIKE DEVICES. THE SALES REP CONFIRMED THAT NOTHING BROKE IN THE PATIENT AND THAT THEY REALIZED THAT NEEDLE BROKE WHEN THEY SAW THE TIP ON THE TABLE. ALSO, THE NEEDLE IS NOW STUCK IN THE GUN. THE DEVICES WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7475988 ↗