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

Model Number	HR104
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation and no lot number has been provided to applied medical.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: pth voie anterieur.Event description: the alexis was in position, after using the sharp tools like the rasp, the alexis teared from the side.The patient was obese, so additional forces was needed.Additional information received from applied medical representative via 30jan25: the patient's status is good, no impact whatsoever, and no injury.Intervention: no additional intervention was needed.Patient status: the patient's status is good, no impact whatsoever, and no injury.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation, and the lot number was not provided.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 the description of the event, it is likely that a sharp object or instrument came into contact with the sheath, resulting in a hole or tear that further propagated during use.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.
Event or Problem Description
Procedure performed: pth voie anterieur.Event description: the alexis was in position, after using the sharp tools like the rasp, the alexis teared from the side.The patient was obese, so additional forces was needed.Additional information received from applied medical representative via 30jan25: the patient's status is good, no impact whatsoever, and no injury.Intervention: no additional intervention was needed.Patient status: the patient's status is good, no impact whatsoever, and no injury.

• Brand Name: ALEXIS ORTHOPAEDIC PROTECTOR
• 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: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 21426704
• Report Number: 2027111-2025-00373
• Device Sequence Number: 15401882
• Product Code: KGW
• UDI-Device Identifier: 00607915138950
• UDI-Public: (01)00607915138950
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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 Model Number: HR104
• Device Catalogue Number: 101472872
• 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: 01/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: ORTHOPEDIC ANCILLARY
• Patient Sex: Unknown