MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL; BLADE, SCALPEL

Model Number UNKNOWN

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problems Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)

Event Date 11/24/2017

Event Type  malfunction  

Manufacturer Narrative

Deroyal industries, inc.Received notification from the fda of a medwatch report (mw5073708) received through its fda medwatch program.This notification was received by a deroyal representative on (b)(6) 2017.The information received by deroyal did not include sufficient information to open a complaint investigation.Information lacking included a device model number, lot number, and the initial reporter's name and contact.In an attempt to obtain additional information, deroyal opened a corrective and preventive action investigation (b)(4).Ultimately, no additional information could be obtained and no root cause could be determined.Deroyal distributes scalpel blades.It does not manufacture or hold design specifications for the blades.Without a device model number, deroyal is unable to determine the supplier that manufactured the defective blade.Therefore, this medical device report is being reported under the deroyal establishment responsible for complaint handling.If new and critical information is received, deroyal will reopen its investigation and update this report.

Event Description

A #15 scalpel blade fractured during surgical procedure.Required use of fluoroscopic to locate remaining piece in right foot 1st mpj area.Caused a 30-minute delay locating scalpel fragment.Piece was located and removed.Diagnosis or reason for use: bunionectomy.

• Brand Name: DEROYAL
• Type of Device: BLADE, SCALPEL
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 7464023
• MDR Text Key: 106879419
• Report Number: 1043214-2018-00001
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2018
• 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
• Patient Outcome(s): Other