MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD SURG PAT XRAY 1/2X1 1/2; SURGICAL PATTIES

Catalog Number	801404
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device involved in the reported incident is not available for evaluation.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 the surgical pattie (id 801404) string was lost during a surgery (posterior bilateral lumbar decompression at l2-5).The wound was irrigated and thoroughly searched.The room, drapes, gowns, back table, and trash containers were also inspected.The patties were moistened for an hour and was not altered or cut from original size prior to use.The patties were soaked during use.An x-ray was taken to ensure that the string was not inside the patient.The event did not led to a significant surgical delay, and as of right now, no adverse effect on the patient.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The surgical pattie (b)(6) was not returned for evaluation as the product is not available for return as per customer.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined.However, a probable root cause for the reported complaint may be related to inadequate weld strength of the string to the pattie's surface.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 august 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.

• Brand Name: SURG PAT XRAY 1/2X1 1/2
• Common Device Name: SURGICAL PATTIES
• 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: 20078374
• Report Number: 3014334038-2024-00178
• Device Sequence Number: 7765059
• Product Code: HBA
• UDI-Device Identifier: 10381780515005
• UDI-Public: 10381780515005
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

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: 801404
• Device Lot Number: 6561126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2022
• 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 Age: 68 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White