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U.S. Department of Health and Human Services

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

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DEROYAL INDUSTRIES, INC. JIT LAMINECTOMY PACK GENERAL SURGERY TRAY Back to Search Results
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.

 
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Brand NameJIT LAMINECTOMY PACK
Type of DeviceGENERAL 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 Key9125711
MDR Text Key194202903
Report Number3005011024-2019-00013
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK842648
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received09/26/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number89-2569
Device LOT Number50224803
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/04/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/29/2019
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

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