MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES HR004, S/M ALEXIS ORTHO PROT 5/BX; RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number	HR004
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Name of procedure performed: tha.Description of event: [facility].English version of cer: after broaching once or twice for tha, alexis was found to have a hole.Doctor continued to use the product without replacing it until he completed the surgery.It has been confirmed that no fragments of alexis remain in the surgical field.There was no impact to the patient.The doctor in charge is the 11th case of using alexis orthopedic protector.The facility recognizes that if it interferes violently, a hole will open, but they seem that it has some durability.Since it was easily damaged this time, it was confirmed that it was a malfunction.It has been almost 1 week since the surgery date for the applied side to obtain the information this time.It took a long time to get information from the facility to the agency because there seemed to be an in-hospital process.The facility is requesting an investigation report from the manufacturer.The doctor in charge knows that it will take several months for the report from applied to come out.English translation of japanese version of cer: after broaching once or twice with tha, it was found that there was a hole.After that, i continued to use it as it was, but it was confirmed that it was a malfunction because it was easily torn even though it was a durable product.Type of intervention: the surgery was completed with the same device.Patient status: no impact to the patient.
Additional Manufacturer Narrative
The event unit is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection of the returned unit confirmed that there were holes in the sheath material.Based on the 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.
Event or Problem Description
Name of procedure performed: tha.Description of event: [facility].English version of cer: after broaching once or twice for tha, alexis was found to have a hole.Doctor continued to use the product without replacing it until he completed the surgery.It has been confirmed that no fragments of alexis remain in the surgical field.There was no impact to the patient.The doctor in charge is the 11th case of using alexis orthopedic protector.The facility recognizes that if it interferes violently, a hole will open, but they seem that it has some durability.Since it was easily damaged this time, it was confirmed that it was a malfunction.It has been almost 1 week since the surgery date for the applied side to obtain the information this time.It took a long time to get information from the facility to the agency because there seemed to be an in-hospital process.The facility is requesting an investigation report from the manufacturer.The doctor in charge knows that it will take several months for the report from applied to come out.English translation of japanese version of cer: after broaching once or twice with tha, it was found that there was a hole.After that, i continued to use it as it was, but it was confirmed that it was a malfunction because it was easily torn even though it was a durable product.Type of intervention: the surgery was completed with the same device.Patient status: no impact to the patient.

• Brand Name: HR004, S/M ALEXIS ORTHO PROT 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: 14316711
• Report Number: 2027111-2022-00590
• Device Sequence Number: 14696474
• Product Code: KGW
• UDI-Device Identifier: 00607915123185
• UDI-Public: (01)00607915123185(17)241007(30)01(10)1432431
• 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): 07/22/2022

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: 10/07/2024
• Device Model Number: HR004
• Device Catalogue Number: 101428801
• Device Lot Number: 1432431
• 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: 04/12/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2021
• 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
• Patient Sex: Unknown