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

Model Number 89-2569

Device Problems Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/29/2019

Event Type  malfunction  

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 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
• Type of Device: GENERAL SURGERY TRAY
• 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: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 9125711
• MDR Text Key: 194202903
• Report Number: 3005011024-2019-00013
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00749756281393
• UDI-Public: 00749756281393
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K842648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1