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

Catalog Number	245404
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported a neuro surgical patty (id 245404) was easily pulled off the string before the procedure.The entire pack was isolated and removed from the operative room (or).No patient injury reported, and the event did not lead to surgical delay.
Additional Manufacturer Narrative
The surgical patty (id 245404) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause of the reported issue could not be determined.However, a potential cause of the reported failure may be related to the string weld process, during production.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.A corrective and preventative action (capa) was closed in (b)(6) 2024 for the patties/strips product family related to x-ray polymer issues, string issues and incorrect count.Actions were implemented to minimize the issues above.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The surgical pattie (id 245404) was returned for evaluation.Device history record (dhr) ¿ the batch record was reviewed for any anomalies or non-conformances related to the finished device, and none were identified.Failure analysis - all welds were found to be acceptable.Recorded weld settings in the product traveler were found to be within specifications.All pull test records were observed to be passing.The complaint could not be verified through failure analysis.Root cause analysis - the root cause is undetermined and was unable to be confirmed in the complaint evaluation.
Event or Problem Description
N/a.

• Brand Name: BULK SURG PAT 1/2 X 1/2
• 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: 20694708
• Report Number: 3014334038-2024-00214
• Device Sequence Number: 15070667
• Product Code: HBA
• UDI-Device Identifier: 10381780513377
• UDI-Public: 10381780513377
• Combination Product (Y/N): N
• PMA/510(K) Number: K193346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 245404
• Device Lot Number: 7287473
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: 01/15/2025; 03/06/2025
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 01/30/2025; 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2023
• 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