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

Model Number	89-9584
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: an internal complaint (call 48988) was received for a convenience kit (part 89-9584, lot 50837626) that contained a skin hook that failed during use.Specifically, the hook broke while being used in an excision, creating a risk for a foreign body to be left in the surgical site.The defective sample was returned for evaluation.The hook was broken, confirming the reported event.The work order for reported lot number was reviewed for possible discrepancies that may have contributed to the reported issue.No discrepancies were found.The bill of materials was reviewed to identify the affected kit component.The relevant raw material was identified as 1154327, which is supplied to deroyal by (b)(4).This raw material comes to deroyal in bulk.It is examined during sub-assembly for rust and debris.Product on hand of the affected raw material was reviewed for any defective or broken skin hooks.None were found.The 2017-2019 supplier corrective action request (scar) and supplier notification letter logs were reviewed for previous similar complaints.No previous issues were identified; however, due to the nature of the report, a scar was issued to fine surgical.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 or Problem Description
A skin hook packaged in a convenience kit broke while being used in an excision.The tip was extricated to prevent a foreign body being left in the surgical site.
Event or Problem Description
A skin hook packaged in a convenience kit broke while being used in an excision.The tip was extricated to prevent a foreign body being left in the surgical site.
Additional Manufacturer Narrative
Root cause: the kit component is supplied to deroyal by fine surgical instruments, inc.Therefore, a supplier corrective action request (scar) was issued to fine surgical.In its scar response, the supplier stated it received a sample for evaluation but was unable to determine the cause of the tip breaking from this sample.Corrective action: in its scar response, fine surgical stated it performed a complete inspection of its inventory.All product on hand met its standard specifications.Investigation summary: an internal complaint (call 48988) was received for a convenience kit (part 89-9584, lot 50837626) that contained a skin hook that failed during use.Specifically, the hook broke while being used in an excision, creating a risk for a foreign body to be left in the surgical site.The defective sample was returned for evaluation.The hook was broken, confirming the reported event.The work order for reported lot number was reviewed for possible discrepancies that may have contributed to the reported issue.No discrepancies were found.The bill of materials was reviewed to identify the affected kit component.The relevant raw material was identified as 1154327, which is supplied to deroyal by fine surgical instruments.This raw material comes to deroyal in bulk.It is examined during sub-assembly for rust and debris.Product on hand of the affected raw material was reviewed for any defective or broken skin hooks.None were found.The 2017-2019 supplier corrective action request (scar) and supplier notification letter logs were reviewed for previous similar complaints.No previous issues were identified; however, due to the nature of the report, a scar was issued to fine surgical.A response was received april 6, 2020 and accepted by deroyal personnel.The investigation is complete at this time.If new and critical information is received, this report will be updated.

• Brand Name: OPC DERMATOLOGY SURGICAL PACK
• Common Device Name: DISPOSABLE SURGICAL INSTRUMENT KIT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette, tn TN 37766
• MDR Report Key: 9590484
• Report Number: 3005011024-2019-00017
• Device Sequence Number: 516666
• Product Code: KDD
• UDI-Device Identifier: 00749756915281
• UDI-Public: 00749756915281
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 89-9584
• Device Lot Number: 50837626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1