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	03/28/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Procedure performed: total hip arthroplasty.Description of event: [name] hospital.This is a complaint from the market.Report from the sales rep.When using a reamer, it hit the protector and tore the sheath.Clinical sample and not accustomed to using the protector.So, reamer hit it.This unit will not be returned.Discarded at hospital due to infection (hbs antigen +).Type of intervention: the product was removed and surgery continued.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, photos of the event unit were provided.Visual inspection confirmed the complainant¿s experience of sheath tear.It was also noted the tear was jagged and there were several missing fragments in the sheath.Based on the description of the event and the photos provided, it is likely that a sharp object or instrument came into contact with the sheath, resulting in the tear and fragmentation.
Event or Problem Description
Procedure performed: total hip arthroplasty.Description of event: [name] hospital.This is a complaint from the market.Report from the sales rep.When using a reamer, it hit the protector and tore the sheath.Clinical sample and not accustomed to using the protector.So, reamer hit it.This unit will not be returned.Discarded at hospital due to infection (hbs antigen +).Type of intervention: the product was removed and surgery continued.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: 19177276
• Report Number: 2027111-2024-00604
• Device Sequence Number: 6342311
• Product Code: KGW
• UDI-Device Identifier: 00607915138950
• UDI-Public: (01)00607915138950(17)260814(30)01(10)1500860
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2024

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: 08/14/2026
• Device Model Number: HR104
• Device Catalogue Number: 101472872
• Device Lot Number: 1500860
• 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: 03/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2023
• 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: HAMMER FOR REAMER INSTALLATION.
• Patient Sex: Unknown