MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES HR104, S/M ALEXIS FLEX ORTHO PROT 5/BX; 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	03/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: tha.Description of event: [name] hospital.This is a complaint from the market.Report from the sales rep via email; the seam of the alexis sheath ripped several centimeters.The surgeon noticed that the sheath was ripped when he removed it.No other instruments are in contact with the sheath.See attached for a photo of the sheath tear.This unit will not be returned.Type of intervention: na.Patient status: no impact.
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.However, a photo of the event unit was provided.Visual inspection confirmed the complainant¿s experience of sheath separation at the seam.Based on the description of the event and the photos provided, it is likely that the sheath was manufactured with a weak film-to-film seal.Furthermore, the sheath likely separated due to stresses experienced during use.
Event or Problem Description
Procedure performed: tha.Description of event: [name] hospital.This is a complaint from the market.Report from the sales rep via email.The seam of the alexis sheath ripped several centimeters.The surgeon noticed that the sheath was ripped when he removed it.No other instruments are in contact with the sheath.See attached for a photo of the sheath tear.This unit will not be returned.Type of intervention: na.Patient status: no impact.

• Brand Name: HR104, S/M ALEXIS FLEX 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: 19176044
• Report Number: 2027111-2024-00603
• Device Sequence Number: 6367789
• Product Code: KGW
• UDI-Device Identifier: 00607915138950
• UDI-Public: (01)00607915138950(17)260627(30)01(10)1496902
• 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): 08/02/2024

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: 06/27/2026
• Device Model Number: HR104
• Device Catalogue Number: 101472872
• Device Lot Number: 1496902
• 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: 04/01/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 08/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2023
• 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
• Patient Sex: Unknown