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

Model Number 89-8554

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

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

Event Date 03/14/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: an internal complaint ((b)(4)) was received indicating that a face lift pack (part 89-8554, lot 45465750) contained a 4 x 4 gauze that was falling apart during the procedure, requiring physicians to pick pieces off the patient before closing.A sample was initially reported to be available for return.However, as of the date of this report, that sample has not been received.The work order for the reported lot number was reviewed for discrepancies that may have contributed to the reported issue.However, no discrepancies were identified.The bill of materials for the finished good convenience kit was reviewed and the affected component was identified as a raw material 5-19925, a 4 x 4 gauze that is supplied to deroyal by meixin medical.The 2017-2019 supplier corrective action request (scar) and supplier notification letter (snl) logs were reviewed for similar complaints.No previous complaints for this reported issue were identified.However, due to the nature of the report, a scar was issued to meixin medical.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

The 4 x 4 gauze packaged in a convenience kit fell apart during a procedure.The physicians had to pick pieces off of the patient before closing.

Manufacturer Narrative

Root cause: the gauze contained within the convenience kit is supplied to deroyal by meixin medical.A supplier corrective action request (scar) was issued to meixin medical, and in its response, the manufacturer identified two possible root causes for the reported issue.First, the surface of the gauze may have attached with off-cut gauze debris.That is, during the production or the gauze-cutting process, the operators did not clean the work area in a timely manner, and the accumulated off-cut gauze debris may get attached to the finished good.Second, there may have been damage on the original raw material gauze fabric, and the operators did not remove the damaged gauze during production.The damaged raw material may have made it into the finished good, which fell apart when used.Corrective action: an engineering change order has been entered at deroyal to change the gauze the reported end user receives in the finished good convenience kit.Additionally, the supplier responded in its scar that it has emphasized to its workers to follow the internal environmental control procedure to keep their work area tidy.The workshop supervisor is required to monitor the work environment at all times to ensure conformity and avoid foreign debris attaching to the product.Additionally, the qa inspector shall tighten the incoming inspection of raw material gauze for damage.Workers were re-trained on the production operation procedure, emphasizing that they should remove any non-conforming product as specified.Investigation summary an internal complaint (call 46668) was received indicating that a face lift pack (part 89-8554, lot 45465750) contained a 4 x 4 gauze that was falling apart during the procedure, requiring physicians to pick pieces off the patient before closing.A sample was initially reported to be available for return.However, a sample was never returned for evaluation.The work order for the reported lot number was reviewed for discrepancies that may have contributed to the reported issue.However, no discrepancies were identified.The bill of materials for the finished good convenience kit was reviewed and the affected component was identified as a raw material 5-19925, a 4 x 4 gauze that is supplied to deroyal by meixin medical.The 2017-2019 supplier corrective action request (scar) and supplier notification letter (snl) logs were reviewed for similar complaints.No previous complaints for this reported issue were identified.However, due to the nature of the report, a scar was issued to meixin medical.A response was received and accepted april 12 by the deroyal investigator.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

The 4 x 4 gauze packaged in a convenience kit fell apart during a procedure.The physicians had to pick pieces off of the patient before closing.

• Brand Name: FACE LIFT PACK
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• MDR Report Key: 8500813
• MDR Text Key: 147604290
• Report Number: 3005011024-2019-00005
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 50749756025619
• UDI-Public: 50749756025619
• Combination Product (y/n): N
• PMA/PMN Number: K842648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 89-8554
• Device Lot Number: 45465750
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1