MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN SURG STRP1/2X6-200; SURGICAL STRIPS

Catalog Number	801451
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a followup report will be submitted.
Event or Problem Description
A physician reported the codman surgical patties (801451) had numerous cotton like pieces shedding off into the wound causing blockage.The pieces of the cotton were being caught inside the vascular vessels causing the flap to loose blood flow.The procedure was completed with a replacement product available from another manufacturer.The procedure was a bilateral breast reconstruction with deep inferior epigastric perforator flap: bilateral procedure.
Additional Manufacturer Narrative
Additional information received: patient age and gender: 51yr female.Patient race and ethnicity: black or african american.Kindly confirm the exact quantity of the reported item.1 pack (10 strips inside 1 pack) ½ in.Current status of the patient.Discharge home, no reported patient complications.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The surgical patty (id 801451) was returned for evaluation: device history record (dhr)- the batch record was reviewed for any anomalies or reports related to the finished device, and none were identified.Failure analysis - the complaint was confirmed.Product was shown to be delaminating.The lot traveler was inspected, and it was found that the lot was produced prior to the implementation of delamination inspections.Root cause- the complaint was confirmed in the evaluation.Product was shown to be delaminating.The lot traveler was inspected, and it was found that the lot was produced prior to the implementation of delamination inspections.This failure was addressed under a corrective and preventative action (capa) and because this occurred prior to the implementation no retraining is required.Capa has been closed in december 2023 for the patties delamination issue.Capa - implemented preventative actions to minimize the issue reported.
Event or Problem Description
N/a.

• Brand Name: CODMAN SURG STRP1/2X6-200
• Common Device Name: SURGICAL STRIPS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 18698226
• Report Number: 3014334038-2024-00027
• Device Sequence Number: 7205098
• Product Code: HBA
• UDI-Device Identifier: 10381780515074
• UDI-Public: 10381780515074
• Combination Product (Y/N): N
• PMA/510(K) Number: K880402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2024

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 Catalogue Number: 801451
• Device Lot Number: 5747237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/26/2024
• Supplement Date Received by Manufacturer: 02/14/2024; 09/12/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 03/06/2024; 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2021
• 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
• Patient Sex: Unknown