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

Model Number	89-10570
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility medwatch report (#4900240000-2022-8050) was received on (b)(6) 2022 reporting pack contaminated with a black hair inside the basin under the tab with the raytec.A supplier corrective action request (scar) was issued to the gauze supplier meixin medical suzhou, ltd.The sample has not been returned to deroyal for evaluation.However, a picture of the hair was provided.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
Pack contaminated with a black hair inside the basin under the tab with the raytec.
Additional Manufacturer Narrative
A picture of the gauze with the hair was received and evaluated.Root cause: the supplier meixin medical suzhou, ltd.Has determined that the worker may have tidied her cap in the work area and her hair may have fell off, or the worker didn't check the surface of her working clothes after changing, and her clothes may have attached with hair which may subsequently contaminate the product.The following corrective and preventive actions have taken place by the supplier meixin medical suzhou, ltd.Retrain the workers to wear their working clothes and caps in standard way.Whenever found, non-standard wearing shall be corrected in the changing room immediately.After changing, the workers should always check if any hair is attached to the surface of the working clothes.The workshop supervisor instructed to the workers the importance of correct wearing of working clothes to prevent hair contaminating the product.The workshop should paste the diagram for standard wearing for warning purpose.The following corrective actions have taken place by deroyal: added additional guidance to the manufacturing routing instructions to indicate that a previous complaint has been received and to fan out and pay close attention to the two banded packs of gauze.Production records were reviewed, and no issues were found.An inventory check of the gauze was made by deroyal, a total of 200 were 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
• Manufacturer Contact: melissa logsdon ; 200 debusk lane; powell, TN 37849 ; 8653626157
• MDR Report Key: 14453088
• Report Number: 3005011024-2022-00021
• Device Sequence Number: 17731108
• Product Code: LRO
• UDI-Device Identifier: 00749756363587
• UDI-Public: 0749756363587
• 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): 06/15/2022

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: 89-10570
• Device Lot Number: 56432726
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2022
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 06/15/2022
• 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