MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BULK SURG PAT 1/2 X 1; OEM PATTIES & STRIPS

Catalog Number	245406
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medwatch #: (b)(4).A facility reported an incorrect count of surgical patty (id 245406) during initial count.There were only 9 cottonoids in the pack.It was counted twice but only 9 were counted.The products were taken off the field and a new cottonoid was opened.No patient injury reported, and the event did not led to surgical delay.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The surgical patty (id 245406 was returned for evaluation.Device history record (dhr) ¿ the batch records were reviewed for any anomalies or ncs related to the finished device, and none were identified.Failure and root cause analysis - the returned sealed sample was inspected and found to only have 9 of the expected 10 patties present.The complaint can be confirmed.Patties are produced using hybrid equipment which utilize an operator and a semi-automated assembly machine.This hybrid machine produces a stack of 10 patties which an operator then unloads and manually places on a card.The operator is to inspect each stack of 10 for proper count, cleanliness, and discoloration.The operator likely dropped a patty while wrapping the card resulting in 9 of 10 patties.Applicable operators will be retrained to properly inspect the final count.

• Brand Name: BULK SURG PAT 1/2 X 1
• Common Device Name: OEM PATTIES & STRIPS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20015376
• Report Number: 3014334038-2024-00166
• Device Sequence Number: 7476135
• Product Code: HBA
• UDI-Device Identifier: 10381780513391
• UDI-Public: 10381780513391
• 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: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2025

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: 245406
• Device Lot Number: 7265878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown