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

Model Number	89-10570
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility medwatch report (#(b)(4)) was received on 3/2/2023 raytecs in posterior spine pack faulty, the x-ray detectable strip is easily removed from raytec sponge.String came out while cleaning kerrison.A supplier corrective action request (scar) was issued to the raytec supplier meixin medical.The actual sample was 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
Raytecs in posterior spine pack faulty, the x-ray detectable strip is easily removed from raytec sponge.String came out while cleaning kerrison.
Additional Manufacturer Narrative
A user facility medwatch report (b)(4) was received on 3/2/2023 raytecs in posterior spine pack faulty, the x-ray detectable strip is easily removed from raytec sponge.String came out while cleaning kerrison.A supplier corrective action request (scar) was issued to the raytec supplier meixin medical.The actual sample was not available to be returned to deroyal for evaluation.The following root cause was determined by the supplier meixin medical: employee failed to remove the nonconforming product from the line.There was no inventory or work in process on hand to evaluate.The following corrective and preventive actions have been taken by meixin medical: add requirement to regularly monitor the temperature control device which will affect the ironing effect of the xr strip on to the sponge.Once deviation is noticed on the temperature control device, production should be stopped immediately, and the sponges produced before the deviation should be carefully checked.Retrain the employees on the document of mx/qa-gs-04 gauze mechanical folding procedure to enhance their quality awareness.Stress that the employees shall strictly follow the regular monitoring requirement on the temperature control device, to eliminate nonconformance.Production records were reviewed, and no issues were found.An inventory check of the gauze was made by deroyal, a total of 10 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 POSTERIOR SPINE 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
• MDR Report Key: 16573720
• Report Number: 3005011024-2023-00015
• Device Sequence Number: 15241307
• Product Code: LRO
• UDI-Device Identifier: 00749756363587
• UDI-Public: 00749756363587
• 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): 03/22/2023

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: 89-10570
• Device Catalogue Number: 89-10570
• Device Lot Number: 58388870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 03/20/2023
• Supplement Report FDA Received Date: 03/22/2023
• 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