MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. ROSEBUD DISSECTOR; DISSECTOR, SURGICAL, GENERAL AND PLAST

Catalog Number 30-202

Device Problems Degraded (1153); Flaked (1246); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2015

Event Type  malfunction  

Event Description

The blue x-ray detectable strip is flaking off into the surgical field while being used.They opened up five different packs and it was happening to all of them.

Manufacturer Narrative

Investigation findings: the work order was reviewed for discrepancies that would have contributed to the reporting issue.No discrepancies referencing raw material (b)(4), lot number 1197339, were identified.Raw material (b)(4) is supplied to deroyal by (b)(4).The 2013-2015 scar/snl logs were reviewed for similar complaints.No similar complaints for the raw material were identified.(b)(4) has been issued to (b)(4) and is due on 06/05/2015.Follow-up was performed on 06/01/2015 as a reminder of the scar due date.The scar response was initially received on 06/05/2015 and accepted on 06/12/2015.Representative samples of the finished good and lot number reported were obtained after the scar response was provided.Additional communication between the qc complaint specialist and the vendor has occurred to notify them of the sample availability.It has been requested that after the receipt of the sample and evaluation that the scar be updated.Once this occurs, the complaint will be reopened for updates.Correction: a replacement has been provided.Root cause analysis: scar: a true root cause was unable to be determined to a sample or pictures not being provided.The flaking issue is unable to be verified.A review of the dhr for the lot number was reviewed and no discrepancies were recorded.The product may have had abnormal damage and caused the product x-ray element to flake.Corrective action and/or systemic correction action taken: scar: the complaint information was forwarded to our facility to increase awareness for a similar incident.All operators need to inform the supervisor of any discrepancy immediately.Continue to strictly work according to factory sops to monitor and control the production manufacturing process.To ensure the factory's inspection procedures are effective, we have instructed our inspectors to pay special attention when performing inspections of the in-process and finished product.We will continue to monitor for any developing trend for this issue and implement additional corrective/preventive actions as necessary.Training has been conducted.Training record numbers: (b)(4) and (b)(4).Preventive action: scar: a preventive action has not been taken.Investigation is complete at this time.This report will be updated if more information becomes available.

• Brand Name: ROSEBUD DISSECTOR
• Type of Device: DISSECTOR, SURGICAL, GENERAL AND PLAST
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; km 20.5 carretera a villa canales; villa canales ; GT
• Manufacturer Contact: 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 4849984
• MDR Text Key: 5943574
• Report Number: 3010452421-2015-00007
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 30-202
• Device Lot Number: 35935682
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/15/2015
• Event Location: Hospital
• Date Manufacturer Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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
• Patient Outcome(s): Required Intervention