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	Malposition of Device (2616)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	04/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Procedure performed: tha ocm.Event description: [name] hospital.Report from fi.Sample trialed in 4/6 case.It was inserted under the fascia and used.This cer is not a complaint but a health hazard report.Acute thrombotic lower limb arterial occlusion was occurred, probably during and immediately after surgery.The incision was about 8 cm.During rasping, contact with the sheath occurred, causing a hole, but no tearing was observed.There was no particular impact on the intraoperative or operative time.He confirmed that the device would not cause any fragments to fall into the body, although it would make a hole if hit too hard, and continued to use it.The event device was already discarded by hospital.Additional information received on april 14th, via email the patient is conscious and her life is not indanger intervention: this cer is not a complaint but a health hazard report.Acute thrombotic lower limb arterial occlusion was occurred, probably during and immediately after surgery.Patient status: the patient is conscious and her life is not indanger.
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.Based on input provided by a medical subject matter expert, surgeons who are familiar with the device, it is unlikely that the event unit would have resulted in the customer experience of a blood clot.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.
Event or Problem Description
Procedure performed: tha ocm.Event description: [name] hospital.Report from fi.Sample trialed in 4/6 case.It was inserted under the fascia and used.This cer is not a complaint but a health hazard report.Acute thrombotic lower limb arterial occlusion was occurred, probably during and immediately after surgery.The incision was about 8 cm.During rasping, contact with the sheath occurred, causing a hole, but no tearing was observed.There was no particular impact on the intraoperative or operative time.He confirmed that the device would not cause any fragments to fall into the body, although it would make a hole if hit too hard, and continued to use it.The event device was already discarded by hospital.Additional information received on april 14th, via email.The patient is conscious and her life is not indanger.Additional information received via email on 03may2023 by [name].We will report this event to our government.We heard this patient was transferred to another hospital that can care the vessel treatment.Intervention: this cer is not a complaint but a health hazard report.Acute thrombotic lower limb arterial occlusion was occurred, probably during and immediately after surgery.Patient status: the patient is conscious and her life is not indanger.

• 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: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 16856475
• Report Number: 2027111-2023-00432
• Device Sequence Number: 18024776
• Product Code: KGW
• UDI-Device Identifier: 00607915123185
• UDI-Public: (01)00607915123185(17)241214(30)01(10)1438282
• 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): 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/14/2024
• Device Model Number: HR004
• Device Catalogue Number: 101428801
• Device Lot Number: 1438282
• Was Device Available for Evaluation?: No
• 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: 04/12/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: REAMERS, IMPLANTS, ETC.; THE USUAL BONE SAWS, RASPING
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female