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	06/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility medwatch report (b)(4) was received reporting contaminated (cmc posterior spine pack).A strand of hair was found in the posterior spine pack after it was opened.Hair was discovered under the blue towel that sits on top of the gown in the pack.The pack was discarded 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
A strand of hair was found in the posterior spine pack after it was opened.Hair was discovered under the blue towel that sits on top of the gown in the pack; pack was discarded, hair was not saved, no picture was taken.(cmc posterior spine pack).
Additional Manufacturer Narrative
A supplier corrective action request (scar) was issued to the towel supplier gd medical and gown supplier o & m halyard medical.Root cause: it was determined by gd medical, that a manufacturing employee in the folding workshop was not properly following the gowning procedure.The following corrective actions have taken place by gd medical: all employees involved in the manufacturing of the reported lot were re-trained on gowning procedure.Root cause: the complaint sample was unavailable for evaluation.Therefore, o & m halyard medical was unable to determine the true root cause for the hair.The following corrective actions have taken place by o & m halyard medical: the manufacturing personnel were made aware of the reported issue of hair being found on gown.Potential root cause: it was determined by deroyal, 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, and debris contained in vendor supplied items.The following corrective actions have taken place by deroyal: manufacturing personnel were retrained on the dress code procedure (corp.Prc.079), 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: CMC POSTERIOR SPINE PACK
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• MDR Report Key: 12258376
• Report Number: 3005011024-2021-00004
• Device Sequence Number: 17393919
• Product Code: LRO
• UDI-Device Identifier: 00749756363587
• UDI-Public: 00749756363587
• 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): 09/17/2021

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: 89-10570
• Device Catalogue Number: 89-10570
• Device Lot Number: 54473479
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1