MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. BIOPSY SPECIALS BACK; DISPOSABLE SURGICAL INSTRUMENT KIT

Model Number 89-9100

Device Problems Unintended Ejection (1234); Mechanical Problem (1384); Ejection Problem (4009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2018

Event Type  malfunction  

Manufacturer Narrative

Root cause: the scalpel contained in the convenience kit is supplied to deroyal by (b)(4).A supplier corrective action request (scar) was issued to (b)(4).In its response, the manufacturer stated that because the sample was not returned, the reported condition could not be confirmed.A precise root cause for the reported defect cannot be established.Possible root causes include equipment malfunction, equipment design, and ergonomics.Corrective action: in its scar response, (b)(4) stated a semi-automatic measurement system has been implemented to address the potential root causes for equipment malfunction and equipment design.A slide has been installed that sends rejected material to the scrap bin to address the potential root cause for ergonomics.A 100% "detachment test" also has been included in inspection.Investigation summary: an internal complaint ((b)(4)) was received for a convenience kit (finished good 89-9100, lot 47444549) that contained a scalpel that malfunctioned during use.The end user reported that the scalpel spring ejected the blade out of the back of the scalpel.The blunt end of the blade hit a physician in the upper arm.A sample was not returned for evaluation.Deroyal's complaint investigator reviewed the work order for possible discrepancies that may have contributed to the reported event.No discrepancies were identified.The bill of materials for the kit was reviewed and the affected component was identified as raw material (b)(4), which is supplied to deroyal by (b)(4).The 2016-2018 scar and supplier notification letter logs were reviewed for similar complaints.No similar complaints were identified; however, due to the nature of the report, a scar was issued to (b)(4).A response was received january 14, 2019, and it was reviewed and accepted by deroyal's complaint investigator.Deroyal will continue to monitor post market feedback and will recognize if this issue reoccurs in the future.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

The scalpel spring ejected the blade out the back of the scalpel, and the blunt end hit the physician on the upper arm.The scalpel was a component in a convenience kit.

• Brand Name: BIOPSY SPECIALS BACK
• Type of Device: DISPOSABLE SURGICAL INSTRUMENT KIT
• 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: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 8261675
• MDR Text Key: 135185424
• Report Number: 3005011024-2018-00018
• Device Sequence Number: 1
• Product Code: KDD
• UDI-Device Identifier: 00749756905374
• UDI-Public: 00749756905374
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 89-9100
• Device Lot Number: 47444549
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2018
• 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