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

Model Number	89-2569
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: an internal complaint ((b)(4)) was received for a convenience kit (part 89-2569, lot 50224803) that contained or towels that created lint during a surgical procedure.A sample was returned 9/4/2019 and confirmed the reported issue.The work order for the reported lot was reviewed for possible discrepancies that may have contributed to the event.No discrepancies were identified.The bill of material for the kit was reviewed and raw material 1060988 was identified as the affected or towel, which is purchased in bulk from a supplier, s2s global.A supplier corrective action request has been sent to s2s global.The returned sample also was forwarded to the supplier for evaluation.As of the date of this report, a response has not been received.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.
Event or Problem Description
Fuzz on the or towels caused lint during a surgical procedure.The or towels were packaged in a convenience kit used during a neurological procedure.

• Brand Name: JIT LAMINECTOMY PACK
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• MDR Report Key: 9125711
• Report Number: 3005011024-2019-00013
• Device Sequence Number: 19482229
• Product Code: LRO
• UDI-Device Identifier: 00749756281393
• UDI-Public: 00749756281393
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K842648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/26/2019

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: Health Professional
• Device Model Number: 89-2569
• Device Lot Number: 50224803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1