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U.S. Department of Health and Human Services

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

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DEROYAL INDUSTRIES, INC. DEROYAL BLADE, SCALPEL Back to Search Results
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.
 
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Brand NameDEROYAL
Type of DeviceBLADE, 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 Key7464023
MDR Text Key106879419
Report Number1043214-2018-00001
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
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 Received04/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/13/2018
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 Treatment Data
Date Received: 04/26/2018 Patient Sequence Number: 1
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