Alexis Wound Protector-Retractor C8322Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00607915132958), received between Jun 7, 2017 and Aug 23, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: BREAST PROCEDURE. DETAILED DESCRIPTION OF EVENT: LIMITED INFORMATION PROVIDED. EMAIL THAT WAS SENT BY FACILITY STATED THAT ALEXIS IS ARRIVING WITH HOLES IN IT. DISCOVERED DURING SURGERY AND COMPLETED THE CASE WITH THE EVENT DEVICE. THIS DID NOT DELAY OR TIME. THERE ARE NO PHOTOS AVAILABLE. PRODUCT WILL BE RETURNED. ADDITIONAL INFORMATION RECEIVED VIA PHONE ON 14AUG2019 FROM APPLIED MEDICAL ACCOUNT MGR. THE HOLES WERE IN THE SHEATH OF THE ALEXIS. THEY DID NOT NOTICE THE HOLES UNTIL THEY REMOVED THE ALEXIS AT THE END OF THE CASE. THE SURGEON HAS BEEN USING THE ALEXIS FOR 2 TO 3 YEARS WITH THE MINI RICHARDSON RETRACTORS AND HAS NOT HAD AN ISSUE. TYPE OF INTERVENTION: COMPLETED WITH SAME DEVICE AS HOLES WERE NOT FOUND UNTIL AFTER THE CASE WAS COMPLETED. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8927268 ↗
• MalfunctionSep 20, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: PARTIAL KNEE ARTHROPLASTY. ON (B)(6) 2018, C8322 XS ALEXIS WOUND PROTECTOR/RETRACTOR, LOT# 1322872, WAS USED BY SURGEON AT MEDICAL CENTER FOR A PARTIAL KNEE ARTHROPLASTY. HE KNEW THAT THE MODEL WAS NOT THE ORTHOPAEDIC VERSION BUT USED IT ANYWAY. DURING THE PROCEDURE, THE ALEXIS PROTECTOR SHEATH WAS TORN BY INSTRUMENTATION. THE STAFF RETRIEVED THE SHEATH BEFORE CONTINUING WITH THE PROCEDURE. SURGEON RECAP OF INCIDENT: DRILLED ONE OF THE PINS THROUGH THE POLYURETHANE AND IT WOUND ITSELF AROUND THE PIN. SURGEON ERROR! I SHOULD HAVE RETRACTED MORE CAREFULLY. ALL THE PIECES WERE WRAPPED AROUND THE PIN NOT LOOSE IN THE KNEE. TYPE OF INTERVENTION: UNKNOWN. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7895055 ↗
• MalfunctionJul 18, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: UNK. "THE SHEAT ATTACHMENT PEELED OFF FROM THE RING APPROXIMATE SIZE 1-2 CM." "OUR CUSTOMER MISTAKENLY THROWN THE ACTUAL USED PRODUCT, SO WE CAN`T RETURN FOR INSPECTION." ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 21JUN2018 FROM, (B)(4), DISTRIBUTOR. "THE INCIDENT OCCUR AFTER PLACEMENT OF THE PRODUCT, WHILE THE DOCTOR TRIED TO ROLL UP THE SHEATH." TYPE OF INTERVENTION: UNK. PATIENT STATUS: UNK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7701083 ↗
• MalfunctionSep 7, 2017Material Perforation; Material Perforation

  PROCEDURE PERFORMED: APPENDECTOMY. EVENT DESCRIPTION: "WHEN A DOCTOR ROLLED THE OUTER RING UP ONCE, THE SHEATH WAS TORN. THE SURGEONS REPLACED THE PRODUCT TO NEW ONE AND STARTED OVER THE PROCEDURE." ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE DISTRIBUTOR, ON (B)(6) 2017. THE DOCTOR ROLLED THE OUTER RING UP OUTWARD ONCE (=INSIDE OUT?)." ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE DISTRIBUTOR, ON (B)(6) 2017: THE NAME OF THE PROCEDURE PERFORMED IS APPENDECTOMY. I CONFIRMED THAT OTHER INSTRUMENTS DIDN'T COME IN CONTACT WITH THE SHEATH. TYPE OF INTERVENTION: REPLACED THE PRODUCT AND "STARTED OVER THE PROCEDURE" PATIENT STATUS: NO PATIENT INJURY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6850512 ↗
• MalfunctionJun 7, 2017Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  NO PROCEDURE PERFORMED/ INSPECTION AT DISTRIBUTION CENTER - "THE PRODUCT DID NOT PASS THE INCOMING INSPECTION. DETAILS ARE SHOWN ON THE ATTACHED FILE." TYPE OF INTERVENTION - NA. PATIENT STATUS - NA.

  Patient problems: No Patient Involvement

  MAUDE report 6619156 ↗