MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORPORATION ALEXIS WOUND PROTECTOR/RETRACTOR; RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number C8302

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/25/2016

Event Type  malfunction  

Event Description

In 2016, customer with a displaced femoral neck fracture underwent a left total hip arthroplasty at this facility.The surgeon performed the procedure described in his note as "complex" and requiring the assistance of a certified physician's assistant to assist with the retraction and other tasks throughout the procedure.Final sponge and needle counts were correct.The customer tolerated the procedure well and was taken to the recovery room in stable condition.There was no mention of any issues with any of the supplies/instruments used during the procedure.A wound protector/retractor was used during the procedure, but was not inspected when removed from the body.This year, this facility was notified by outside facility that during a left hip revision on this patient, there was a retained foreign object (rfo) located--small piece of translucent, thick plastic wrap.The plastic wrap measured approximately 2" by 2".Findings confirmed by their pathology department.The surgeon did disclose to the patient's family that the plastic was not related to the loose implant and had not caused any infection.This surgeon also discussed rfo with surgeon who performed hip initial hip procedure.Both believed the rfo was a piece of the alexis wound protector/retractor, further investigation into the identity of the rfo event at this facility, the surgical team also ruled out supplies, equipment, and the implant as sources for the piece of plastic.The surgical team and surgeon concluded that the rfo was a plastic piece was from the wound proctor/retractor that surgeon uses for hip replacements.Action plan: the surgeon will monitor continued use of the alexis wound protector/retractor ref (b)(4) for hip replacement procedures.The surgeon prefers this model as it is translucent and allows a clear view of the site and visualization for possible bleeders.It does, however, tear easily.If a wound protector is used for hip replacements, all of the other ortho physicians at this facility use the purple-colored fabric, alexis orthopaedic protector.The wound protection/retractor device was not part of the surgical count process and was not inspected after removal from the customer's body.We will re-educate all operating room staff on the concept of verifying that all supplies placed in the body are present/inspected for integrity and accounted for.The surgical techs will verify items are intact during the count process.The surgeon has made it part of his practice to inspect the wound protector/retraction device after removal.

• Brand Name: ALEXIS WOUND PROTECTOR/RETRACTOR
• Type of Device: RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORPORATION; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7147317
• MDR Text Key: 95807232
• Report Number: 7147317
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: C8302
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 79 YR