MAUDE Adverse Event Report: AROA BIOSURGERY LTD. OVITEX REINFORCED TISSUE MATRIX; SURGICAL MESH

Model Number	F10244-1020P
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the relevant batch record was conducted which showed the device lot met all release specifications and no relevant anomalies or non-conformances were noted.No other similar reports have been noted associated with this lot aside from these four recurrences noted.A review of sales records noted that this device lot has been utilized at this hospital 34 times with no other issues reported.Further, ball burst testing was completed on available samples from the same lot.All samples tested met the pre-defined strength specification.It was noted by the surgeon that the hernia recurrence repair was conducted in a different manner as the original repair, thus a surgical assessment of the original repair and the surgical mesh could not be conducted.
Event or Problem Description
A surgeon reported four separate indirect inguinal hernia recurrences after inguinal hernia repair with ovitex core.All recurrences were adressed via a second repair operation.This is one of these four reports.

• Brand Name: OVITEX REINFORCED TISSUE MATRIX
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): AROA BIOSURGERY LTD.; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• Manufacturer (Section G): AROA BIOSURGERY LTD.; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• Manufacturer Contact: tina o'brien ; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• MDR Report Key: 15489487
• Report Number: 3007321028-2022-00035
• Device Sequence Number: 16624158
• Product Code: FTM
• UDI-Device Identifier: 09421904065031
• UDI-Public: 09421904065031
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K153632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: F10244-1020P
• Device Catalogue Number: F10244-1020P
• Device Lot Number: ERT-21K10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2021
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown