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

Model Number	89-9810
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Perforation (2205); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: an internal complaint (call (b)(6)) was received indicating that a convenience kit (finished good 89-9810, lot 48283775) contained a defective light handle cover.The end user reported the light handle cover contained a hole that was not discovered until after the procedure was completed, resulting in contamination to the sterile field.A sample was initially reported to be available.However, as of the date of this report, that sample has not been received.The work order for the reported finished good lot was reviewed for possible discrepancies that may have contributed to the event.No discrepancies were identified.The bill of materials for the kit was reviewed and raw material 755059 was identified as the light handle cover referenced in the complaint report.This raw material is supplied to deroyal by (b)(4).The 2017-2019 supplier corrective action request (scar) and supplier notification letter logs were reviewed for similar complaints.Similar complaints have been identified, and a scar was issued to (b)(4).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
There was a large hole in a light handle cover that was not discovered until after the procedure was completed, thus contaminating the sterile field.The light handle cover was packaged in a convenience kit.
Event or Problem Description
There was a large hole in a light handle cover that was not discovered until after the procedure was completed, thus contaminating the sterile field.The light handle cover was packaged in a convenience kit.
Additional Manufacturer Narrative
Root cause: the affected kit component is supplied to deroyal by steris corporation.Therefore, a supplier corrective action request (scar) was issued to steris.In its response, steris report the true root cause is unknown.The supplier completed an evaluation of its processes, material, and equipment, and no symptoms existed to indicate potential to create holes in light handle covers.It is possible there may have been an intermittent temporary variation in the forming process, but monitoring results have not revealed evidence to confirm that.Corrective action: the supplier reported the following corrective actions: product tooling maintained and cleaned, checks occurring three times per shift to verify compliance, and hourly line checks to verify compliance.Investigation summary an internal complaint (call 46470) was received indicating that a convenience kit (finished good 89-9810, lot 48283775) contained a defective light handle cover.The end user reported the light handle cover contained a hole that was not discovered until after the procedure was completed, resulting in contamination to the sterile field.A sample was initially reported to be available.A sample was returned march 22, 2019, to deroyal.This sample contained a hole, confirming the reported issue.The work order for the reported finished good lot was reviewed for possible discrepancies that may have contributed to the event.No discrepancies were identified.The bill of materials for the kit was reviewed and raw material 755059 was identified as the light handle cover referenced in the complaint report.This raw material is supplied to deroyal by steris corporation.The 2017-2019 supplier corrective action request (scar) and supplier notification letter logs were reviewed for similar complaints.Similar complaints have been identified, and a scar was issued to steris corporation.A response was received and accepted may 21, 2019 by deroyal personnel.The investigation is complete at this time.If new and critical information is received, this report will be updated.

• Brand Name: KNEE PACK
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• MDR Report Key: 8460067
• Report Number: 3005011024-2019-00003
• Device Sequence Number: 16848680
• Product Code: LRO
• UDI-Device Identifier: 00749756945448
• UDI-Public: 00749756945448
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2019

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: 89-9810
• Device Lot Number: 48283775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1