MAUDE Adverse Event Report: RAYNHAM SURG PAT XRAY 1X3 -200; SURGICAL PATTIES

Model Number	801408
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2022
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 contamination/debris was found when opening the sterile surgical patties (id(b)(6)) for a surgery (open septorhinoplasty).No patient contact/injury reported and the event did not led to surgical delay.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields:  d4, d9, g3, g6, h2, h3, h4, h6, h10.The surgical patties (id 801408) are not available for return as per customer; therefore, an evaluation of the device could not be performed.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.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.
Additional Manufacturer Narrative
The surgical patties were returned for evaluation: failure analysis - sample received.Complaint of burn mark on multiple patties confirmed.Brown spots present on 3 patties on the green string and x-ray.Therefor the complaint condition could be confirmed.The complaint root cause was confirmed in the complaint investigation.Cottonoid material is formed from rayon.During processing, this rayon material is broken down into small, loose fibers.If the fibers do not break down properly, a small cluster of fibers can result.This creates a thick spot in the pattie.When the string or x-ray is ultrasonically welded on this spot it absorbs more energy than the rest of the pattie and results in a burn.Patties created on the hybrid machines are visually inspected during the operator before being carded.Operators fan through the stack of 10 patties counting each pattie and ensuring there are no defects.They then flip over the stack and repeat before attaching the stack to a card.Because the burn mark was missed the complaint can be attributed to operator error.Operators identified in the traveler will be retrained per an ils.Therefor the reported complaint reason of (contamination/debris found) was miss identified as the failure analysis confirmed that what was perceived to be contamination was actually burn marks on the product caused in the manufacturing process.A corrective and preventive action (capa) has been closed for the patties/strips product family relate to discoloration, incorrect count, string issues, and x-ray detectability.The capa implemented preventative actions to minimize this issue.

• Brand Name: SURG PAT XRAY 1X3 -200
• Common Device Name: SURGICAL PATTIES
• 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: 15370968
• Report Number: 3014334038-2022-00201
• Device Sequence Number: 1750551
• Product Code: HBA
• UDI-Device Identifier: 10381780515036
• UDI-Public: 10381780515036
• 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,Followup
• Report Date (Section B): 01/05/2023

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: 801408
• Device Catalogue Number: 801408
• Device Lot Number: 6232115
• 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: 08/19/2022
• Supplement Date Received by Manufacturer: 10/13/2022; 11/17/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 10/21/2022; 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2022
• 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