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

Model Number	89-5400
Medical Device Problem Codes	Component Missing (2306); Device Misassembled During Manufacturing /Shipping (2912); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: an internal complaint (call 48964) was received for a convenience kit (part 89-5400, lot 50905191) that contained 14 lap sponges instead of 15.No sample was available for return.The work order was reviewed for possible discrepancies that may have contributed to the reported event.No discrepancies were identified.The bill of materials was reviewed and the affected kit component was identified as raw material 5-1918, which is supplied to deroyal by (b)(4).This material comes to deroyal in bulk with the sponges banded together in stacks of five.These stacks are not unbanded during the convenience kit assembly process.Deroyal employees do not count the amount of lap sponges in each banded stack.A supplier corrective action request (scar) was issued to (b)(4).As of the date of this report, a response has not been received.The 2017-2019 scar and supplier notification letter logs were reviewed for similar complaints, and similar, previous complaints were identified.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.
Event or Problem Description
A convenience kit came with fourteen lap pads instead of fifteen.This was identified during the initial count.No harm to the patient reported.
Event or Problem Description
A convenience kit came with fourteen lap pads instead of fifteen.This was identified during the initial count.No harm to the patient reported.
Additional Manufacturer Narrative
Root cause: the sponges contained within the convenience kit are supplied to deroyal by gd medical.Therefore, a supplier corrective action request (scar) was issued to gd medical.In its response, the supplier stated all lap sponges proceed through a rigorous count verification process that includes a manual counting and machine counting.Each lap sponge pack is counted by workers on site before being passed along a conveyor belt for machine counting.Additionally, the paper bands used to band the sponges are designed to fit only five sponges.A count variance can be easily identified at the banding process.As a result, the probability of a count variance is slim.Corrective action: the aql level for finished product inspection will be adjusted to further reduce the probability of occurrence.Investigation summary an internal complaint ((b)(4)) was received for a convenience kit (part 89-5400, lot 50905191) that contained 14 lap sponges instead of 15.No sample was available for return.The work order was reviewed for possible discrepancies that may have contributed to the reported event.No discrepancies were identified.The bill of materials was reviewed and the affected kit component was identified as raw material 5-1918, which is supplied to deroyal by gd medical.This material comes to deroyal in bulk with the sponges banded together in stacks of five.These stacks are not unbanded during the convenience kit assembly process.Deroyal employees do not count the amount of lap sponges in each banded stack.A supplier corrective action request (scar) was issued to gd medical.A response was received february 7, 2020 and accepted by deroyal personnel.The 2017-2019 scar and supplier notification letter logs were reviewed for similar complaints, and similar, previous complaints were identified.The investigation is complete at this time.If new and critical information is received, this report will be updated.

• Brand Name: TOTAL KNEE PACK
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette, tn TN 37766
• MDR Report Key: 9580996
• Report Number: 3005011024-2019-00016
• Device Sequence Number: 667494
• Product Code: LRO
• UDI-Device Identifier: 00749756635929
• UDI-Public: 00749756635929
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2020

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: 89-5400
• Device Lot Number: 50905191
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1