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

Model Number	F10244-1020P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Type of Reportable Event	Serious Injury
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.
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.

• Brand Name: OVITEX REINFORCED TISSUE MATRIX
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): AROA BIOSURGERY; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• MDR Report Key: 15481512
• Report Number: 3010513348-2022-00008
• Device Sequence Number: 15191648
• Product Code: FTM
• UDI-Device Identifier: 09421904065031
• UDI-Public: 09421904065031
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2022
• Report Date (Section F): 09/24/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/26/2022
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/24/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/24/2022