MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES HR004, S/M ALEXIS ORTHO PROT 5/BX RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number HR004

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2021

Event Type  malfunction  

Manufacturer Narrative

Event unit will not return to applied medical for evaluation. A follow-up report will be provided upon completion of the investigation.

Event Description

Name of procedure being performed "tha als approach with a 10 cm incision. " detailed description of event: complaint based on feedback id #: (b)(4). Submitted 23feb2021. Hospital: [name], (b)(6). "report from [name]. Using (b)(4) in first case in this hospital. Patient (female, thin) in supine position. " "the fixation of the inner ring was poor, and the orthopedic surgeon put it on and took it off several times during the operation, but the fixation of the vastus lateralis muscle was not stable throughout. The outer ring was wrapped inside. This is intraoperative view, metal retractors are used, but inner-ring is not stable. Additional information received via email on 26feb2021 from [name]. Cer form has been provided. "patient was old female. Anterior lateral approach and skin incision was 10cm. Alexis inner ring was placed below the vastus lateralis and outer ring was rolled down inward. Inner ting was not stable at the position and popped out. Surgeon commented inner ring did not fit in. Metal retractor was also used along with alexis. " product is not available for return. Patient status: no patient injury indicated. Type of intervention surgeon put it on and took it off several times during the operation. Metal retractors were also used alongside the device.

• Brand Name: HR004, S/M ALEXIS ORTHO PROT 5/BX
• Type of Device: RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: wendy kobayashi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138059
• MDR Report Key: 11478129
• MDR Text Key: 250365247
• Report Number: 2027111-2021-00386
• Device Sequence Number: 1
• Product Code: KGW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/05/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: HR004
• Device Catalogue Number: 101428801
• Device Lot Number: 1399866
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 02/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial