MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. SPONGE NEURO; NEUROSURGICAL PADDIE

Model Number	5-1015
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility medwatch report (#(b)(4)) was received on 02/21/2023 reporting small blue strip on codman 0.5x0.5 neuro patties that come inside the crani pack kit.After getting all 10 patties off the field, one patty was noted to be missing the blue strip and was unable to be found.There was no injury, additional treatment and or intervention reported within the medwatch.A supplier corrective action request (scar) was issued to the neuro patty supplier integra lifescience.The sample is not available to be returned to deroyal for evaluation.This investigation is ongoing at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.
Event or Problem Description
Small blue strip on codman 0.5x0.5 neuro patties that come inside the crani pack kit.After getting all 10 patties off the field, one patty was noted to be missing the blue strip and was unable to be found.
Additional Manufacturer Narrative
A user facility medwatch report (#3902560000-2023-8004) was received on 02/21/2023 reporting small blue strip on codman 0.5x0.5 neuro patties that come inside the crani pack kit.After getting all 10 patties off the field, one patty was noted to be missing the blue strip and was unable to be found.There was no injury, additional treatment and or intervention reported within the medwatch.A supplier corrective action request (scar) was issued to the neuro patty supplier integra lifescience.The product was not returned therefore, a complete evaluation could not be performed.A device history record review was performed by integra lifescience and concluded that there is no indication that the production process may have contributed to this complaint and all test results passed procedural specifications.Potential root causes were determined by the supplier integra lifescience to be a kink present in the x-ray material, the x-ray feed was blocked with debris, the x-ray feed rollers have lose abrasive properties (not gripping and feeding material correctly), a dull and/or damaged x-ray cutting mechanism, the blade is misaligned with x-ray elevator, the dancer arm jams, there is inadequate x-ray elevator pressure, or obstruction.Due to the root cause finding there were no specific corrective and or preventive actions taken by integra lifescience.However, they will continue to follow their quality system processes for trending of any similar complaints.This issue is being further investigated under an initiated corrective/preventive action plan.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: SPONGE NEURO
• Common Device Name: NEUROSURGICAL PADDIE
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer Contact: melissa logsdon ; 200 debusk lane; powell, TN 37849 ; 8653626157
• MDR Report Key: 16452263
• Report Number: 3005011024-2023-00012
• Device Sequence Number: 12145114
• Product Code: HBA
• UDI-Device Identifier: 00381780513370
• UDI-Public: 00381780513370
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2023

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
• Device Model Number: 5-1015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown