MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. OPC DERMATOLOGY SURGICAL PACK; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Model Number 89-9584

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

A complaint was received on 12/11/2023 reporting the skin hook tip broke off during use.Tip had to be fished out of incision.The sample is not available for returned to deroyal.A supplier corrective action request (scar) was issued to the skin hook supplier fine surgical instrument corp.This investigation is ongoing at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

Event Description

The skin hook tip broke off during use.Tip had to be fished out of incision.

Manufacturer Narrative

A complaint was received on (b)(6)2023 reporting the skin hook tip broke off during use.Tip had to be fished out of incision.The sample was not available to be returned to deroyal.A supplier corrective action request (scar) was issued to the skin hook supplier fine surgical instrument corp.Supplier fine surgical corp.Determined there was an area which could have contributed to the skin hook breaking.Since the working area of skin hook is very delicate, it might have been damaged during the procedure.The following corrections have been taken by the supplier fine surgical corp.To ensure correct material composition instruments were lab tested to ensure the hardness was according to specifications.The lab results confirmed that the products tested were within the required specifications.Hooks were handled with great care throughout the process.All the hooks point areas were covered with point protectors so that no damage occurred during handling and transportation.The following corrective and preventive actions have been taken by fine surgical corp.The entire stock was 100% quality control inspected.All personnel involved in manufacturing, inspection and packing were retrained so they are aware of the reported issue and their consequences so that they would pay special attention to the product.Hooks were press checked against hard objects during inspection.All pieces are reinspected under magnifying glasses to completely ensure there is no damaged tip.All pieces undergoing these processes are sufficiently durable to endure future utilization.Another team was hired for pre-shipping 100% inspection of all the packed material.This action is to further help prevent such errors happening again.Production records were reviewed, and no issues were found.An inventory check of the skin hook was made by deroyal, a total of 50 of the 1154327 were inspected, and no discrepancies were identified during the inspection.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: OPC DERMATOLOGY SURGICAL PACK
• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• 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: melissa logsdon ; 200 debusk lane; powell, TN 37849 ; 8653626157
• MDR Report Key: 18464112
• MDR Text Key: 332988029
• Report Number: 3005011024-2024-00001
• Device Sequence Number: 1
• Product Code: KDD
• UDI-Device Identifier: 00749756915281
• UDI-Public: 00749756915281
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 89-9584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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