MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. CMC EXTREMITY PACK; GENERAL SURGERY TRAY (KIT)

Model Number	89-10552
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint was received on 02/03/2023 reporting xray sponges had thread coming out of the sponges.They were falling apart.A supplier corrective action request (scar) was issued to the sponge supplier meixin medical.The sample has not been returned to deroyal for evaluation at this time.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
Xray sponges had thread coming out of the sponges.They were falling apart.
Additional Manufacturer Narrative
A user facility medwatch report (b)(4) was received reporting xray sponges had thread coming out of the sponges.They were falling apart.A supplier corrective action request (scar) was issued to the sponge supplier meixin medical.A picture of the sample was provided to deroyal for evaluation.The picture showed an issue with gauze instead of a sponge that was initially reported.The following root cause was determined by the supplier meixin medical: the picture shows that the blue xr filament is falling out from the gauze in whole.There is no debris of yarn attached to the xr filament, which indicates that the xr filament is not adhering to the gauze solidly enough.The xr filament will be heated, softened, and then pressed on to the gauze.Key factors that will affect the solidity of the adhering are the temperature and the pressure.The manufacture record of the complaint lot was reviewed, and it was found that the heating system of the folding machine malfunctioned once during production.Employees failed to remove the nonconforming products.There was no inventory or work in process on hand to evaluate.The following corrective and preventive actions have been taken by meixin medical: the folding machine shall be checked and maintained regularly as required.The folding machine shall be stopped and repaired immediately if any abnormalities or malfunctions occur.The products produced before and after the malfunction shall be isolated and inspected retroactively to avoid nonconforming products.The employees were retrained on how to properly identify nonconforming products.Production records were reviewed, and no issues were found.An inventory check of the gauze was made by deroyal, a total of 2000 of the 5-19928 gauze was inspected, and no discrepancies were identified during the inspection.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: CMC EXTREMITY PACK
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• 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: 16311729
• Report Number: 3005011024-2023-00009
• Device Sequence Number: 7049278
• Product Code: LRO
• UDI-Device Identifier: 00749756363549
• UDI-Public: 00749756363549
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K842648
• 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): 03/07/2023

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: 89-10552
• Device Catalogue Number: 89-10552
• Device Lot Number: 58444940
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/03/2023
• Supplement Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 03/07/2023
• 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