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

Model Number 89-7602

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2022

Event Type  malfunction  

Event Description

Raytecs have fallen apart in 2 packs.The blue radio detecting strips are falling out of the raytecs and inside patients.The blue strips are not woven into the white raytec like normal.

Manufacturer Narrative

A complaint was received on 11/7/2022 reporting raytecs have fallen apart in 2 packs.The blue radio detecting strips are falling out of the raytecs and inside patients.The blue strips are not woven into the white raytec like normal.A sample of the gauze was provided to deroyal for evaluation and a picture of the gauze was supplied to meixin medical.A supplier corrective action request (scar) was issued to the gauze supplier meixin medical.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 (b)(4) 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: LAMINECTOMY PACK
• Type of Device: 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: 15885367
• MDR Text Key: 307834732
• Report Number: 3005011024-2022-00035
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00749756742887
• UDI-Public: 00749756742887
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K842648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/30/2022

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: 89-7602
• Device Lot Number: 57746495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1