MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8401, S ALEXIS O WND PROT/RET 5/BX; RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number	C8401
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	04/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure performed: laminectomy.Description of event: [facility] english version of event description: when the attending physician removed alexis at the end of surgery, he checked the surface of alexis and confirmed that there were holes.The shape of the holes appears to be crushed visually.At that time, it was confirmed whether or not the debris had fallen into the body cavity, the debris was found, and the confirmed debris was taken out.The doctor also matched the perforated alexis with the debris, but the doctor wasn't sure if all the debris could be removed from the body cavity.The facility asks the manufacturer for their views on the risks of residual debris in the body cavity.The facility stated that the instruments used violently interfered with alexis during a series of surgical procedures, which is believed to be the cause of the damage.The postoperative course of the patient is so far good.The used instruments are reamer, drill, hammer, bone saw, bone head remover, rasp and so on.Translated japanese version of event description: used in surgery for spinal canal stenosis.I used it according to the attached text, but when i removed the retractor after the surgery, some damage was seen, so i will report it.Instrument usage example) cups, modular heads, reamer, hammer, drill, bone saw, bone head remover, rasp etc.At what stage of the procedure did the problem occur? in the middle of the procedure what is the device (combination device) used in alexis? the above can be considered how was the equipment used in alexis used? when i cut or scraped the bone, i put in and out the sample of the head and stem.Is alexis torn or shattered? it is visually damaged and crushed.Can you tell me the details of the operation of the device (what kind of operation when doing it, etc.) that "violently interfered with the sheath while operating the device"? it is a series of surgical operations, not a specific operation.The customer requests the investigation report.Lot traces to 1019226.Product is available for return.Type of intervention: "the debris was found, and the confirmed debris was taken out." patient status: the skin irritation was occurred by using this product.This irritation has already cured.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection of the returned unit confirmed there were tears and scratches in the sheath material.Based on condition of the returned unit and the description of the event, it is likely that the reported event was caused by an instrument that came in contact with the sheath during the procedure.The event unit was used in a laminectomy procedure, which indicates that the device was used off label.Per the instructions for use (ifu), "the alexis o wound protector/ retractor is a device that allows the surgeon to access the abdominal cavity through an atraumatically retracted wound, providing maximum exposure with minimum incision size.In addition, indicated sizes may be used to access the thoracic cavity or other soft tissue retraction during cardiac and general surgical procedures." the probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Name of procedure performed: laminectomy description of event: [facility] english version of event description: when the attending physician removed alexis at the end of surgery, he checked the surface of alexis and confirmed that there were holes.The shape of the holes appears to be crushed visually.At that time, it was confirmed whether or not the debris had fallen into the body cavity, the debris was found, and the confirmed debris was taken out.The doctor also matched the perforated alexis with the debris, but the doctor wasn't sure if all the debris could be removed from the body cavity.The facility asks the manufacturer for their views on the risks of residual debris in the body cavity.The facility stated that the instruments used violently interfered with alexis during a series of surgical procedures, which is believed to be the cause of the damage.The postoperative course of the patient is so far good.The used instruments are reamer, drill, hammer, bone saw, bone head remover, rasp and so on.Translated japanese version of event description: used in surgery for spinal canal stenosis.I used it according to the attached text, but when i removed the retractor after the surgery, some damage was seen, so i will report it.Instrument usage example) cups, modular heads, reamer, hammer, drill, bone saw, bone head remover, rasp etc.At what stage of the procedure did the problem occur? in the middle of the procedure what is the device (combination device) used in alexis? the above can be considered how was the equipment used in alexis used? when i cut or scraped the bone, i put in and out the sample of the head and stem.Is alexis torn or shattered? it is visually damaged and crushed.Can you tell me the details of the operation of the device (what kind of operation when doing it, etc.) that "violently interfered with the sheath while operating the device"? it is a series of surgical operations, not a specific operation.Lot traces to 1019226.Product is available for return.Type of intervention: "the debris was found, and the confirmed debris was taken out" patient status: the skin irritation was occurred by using this product.This irritation has already cured.

• Brand Name: C8401, S ALEXIS O WND PROT/RET 5/BX
• Common Device Name: RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 14338615
• Report Number: 2027111-2022-00591
• Device Sequence Number: 6218017
• Product Code: KGW
• UDI-Device Identifier: 00607915117252
• UDI-Public: (01)00607915117252(17)231119(30)01(10)1400798
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/19/2023
• Device Model Number: C8401
• Device Catalogue Number: 100938801
• Device Lot Number: 1400798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2022
• Supplement Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: REAMER, DRILL, HAMMER, SAW, BONE HEAD REMOVER
• Patient Sex: Unknown