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

Model Number	89-10563
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being filed due to a retrospective review of complaints.This complaint has been reopened for further investigation.A user facility medwatch report (#4900240000-2021- 8091) was received reporting a small hair found in blue small basin from inside deroyal surgical supply pack.Field contaminated.Blue basin and everything inside was thrown out and replaced.Irrisept and lg of vanc to surgical wound per physician.Iv run for 24 hrs.The sample was not returned it was thrown away by the user facility.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 hair found in blue small basin from inside deroyal surgical supply pack.Field contaminated.Blue basin and everything inside was thrown out and replaced.Irrisept and lg of vanc to surgical wound per physician.Iv run for 24 hrs.(anterior hip pack pgybk).
Additional Manufacturer Narrative
Potential root cause: it was determined, but not limited to, possible employee failure to identify debris, possible dress code violation, lack of lab coat cleanliness, cleaning process not followed or inadequate, exposed product in warehouse, natural occurring static, equipment has loose particulate, inadequate customer satisfaction follow-up, possible inadequate controls identified, possible inadequate assembly methods/instructions, and debris contained in vendor supplied items.The following corrective actions have taken place: manufacturing personnel were retrained on the dress code procedure (corp.Prc.079) and cleaning procedure (corp.Prc.086), quality control specialist started conducting routine walk-throughs in raw material storage areas to identify any potentially exposed product, manufacturing personnel were instructed to wipe down production lines after every order, sub-assemblies were created to place all items potentially containing/attracting lint together prior to final assembly, supplier corrective action request (scar) was issued to the lab coat supplier, robust hairnets will be sourced as available, and added additional guidance to the manufacturing instructions to indicate that these products have had reports of debris to increase scrutiny during the assembly process.The deroyal sales representative conducted an initial site visit on (b)(6) 2021 in regards to reported complaints of contamination (hair and debris) in procedure trays and collected various defective product samples.The samples were provided in bulk and were not able to be correlated to the corresponding reported quality events.The sales representative performed a follow-up visit on (b)(6) 2021, and the customer agreed to individually bag each separate complaint sample in the future.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: ANTERIOR HIP PACK PGYBK
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• MDR Report Key: 12258402
• Report Number: 3005011024-2021-00010
• Device Sequence Number: 5002164
• Product Code: LRO
• UDI-Device Identifier: 00749756363983
• UDI-Public: 00749756363983
• Combination Product (Y/N): Y
• 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): 09/15/2021

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
• Operator of Device: No Information
• Device Model Number: 89-10563
• Device Catalogue Number: 89-10563
• Device Lot Number: 54368151
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1