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

Model Number	245404
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
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 a surgical pattie (245404) fell apart during a craniotomy for tumor resection.The product was irrigated and moistened constantly throughout surgery and reirrigated if patties look dry.The procedure was completed with a replacement product available.No patient injury or surgical delay has been reported.
Additional Manufacturer Narrative
Patties & strips (id 245404) has been returned for evaluation- device history record (dhr)- there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis: the pattie/strip unit was inspected using the unaided eye.The failure analyst noted that the x-ray strip is confirmed to be detaching from the product.The complaint could be verified through failure analysis.Root cause: the x-ray strip is confirmed to have been coming detached from the pattie.There is currently an open capa (corrective and preventative action) to investigate the root cause for the product issue.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The surgical patties were not returned for evaluation; however, a picture was provided: dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - product was not returned for failure analysis however a picture was provided that appears to show a 1/2 x 1/2 pattie disintegrated therefore the complaint condition "fell apart" could be confirmed.Root cause - the root cause is undetermined and was unable to be confirmed in the complaint evaluation.Plausible root cause: user misuse / poor procedure planning.

• Brand Name: BULK SURG PAT 1/2 X 1/2
• Common Device Name: OEM PATTIES & STRIPS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16516551
• Report Number: 3014334038-2023-00028
• Device Sequence Number: 6259261
• Product Code: HBA
• UDI-Device Identifier: 10381780513377
• UDI-Public: 10381780513377
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2023

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 Model Number: 245404
• Device Catalogue Number: 245404
• Device Lot Number: 6563907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 03/28/2023; 05/03/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 04/06/2023; 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2022
• 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 Sex: Unknown