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 Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: total hip arthroplasty ¿ direct anterior.Description of event: the rep was not present for the case.The alexis tore during the procedure into multiple pieces.The surgeon noticed at the end of the case when removing the device.The surgeon was able to retrieve all the fragments.It is unknown how the bag tore.The middle of the alexis sheath tore and ripped into little pieces.No tissue was being removed.The device was placed around the thigh near the pelvis above the femur in a 4-5 cm incision.No specimen was manually morcellated for removal.Product is not available for return.Type of intervention: the case was completed with the same device.Patient status: no patient injury.
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation, but lot number is provided.A follow-up report will be provided upon completion of the 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.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.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: total hip arthroplasty : direct anterior.Description of event: the rep was not present for the case.The alexis tore during the procedure into multiple pieces.The surgeon noticed at the end of the case when removing the device.The surgeon was able to retrieve all the fragments.It is unknown how the bag tore.The middle of the alexis sheath tore and ripped into little pieces.No tissue was being removed.The device was placed around the thigh near the pelvis above the femur in a 4-5 cm incision.No specimen was manually morcellated for removal.Product is not available for return.Type of intervention: the case was completed with the same device.Patient status: no patient injury.

• 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: 17671372
• Report Number: 2027111-2023-00587
• Device Sequence Number: 17694098
• Product Code: KGW
• UDI-Device Identifier: 00607915123185
• UDI-Public: (01)00607915123185(17)260323(30)01(10)1485200
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2023

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: 03/23/2026
• Device Model Number: HR004
• Device Catalogue Number: 101428801
• Device Lot Number: 1485200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2023
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2023
• 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: STANDARD ORTHO INSTRUMENTS
• Patient Sex: Unknown