MAUDE Adverse Event Report: MEDLINE RENEWAL DYONICS; ELITE STONECUTTER BUR, (MAROON/YELLOW) 4.0MM

Catalog Number	72200728
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a reprocessed dyonics elite stone cutter bur, (maroon/yellow) 4.0mm, broke during use.Per report, metal shavings were noted in the surgical site and the area was irrigated until clear.There was no report of a serious injury, an adverse patient consequence or prolonged anesthesia related to this incident.Due to the reported event and medical intervention required to clear the surgical site of metal shavings, this medwatch is being filed.The device was returned for evaluation and the complaint could not be confirmed.Upon inspection of the received device, no issues were observed.There was no physical damage to the device.The device was disassembled and no metal shaves were observed.A review of the reprocessing records was performed and indicated that all processes were conducted as required.A definitive root cause could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the surgical site required irrigation after the reprocessed dyonics elite stonecutter bur broke during use and its metal shavings reached the surgical site.

• Brand Name: DYONICS
• Common Device Name: ELITE STONECUTTER BUR, (MAROON/YELLOW) 4.0MM
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• MDR Report Key: 8583367
• Report Number: 3032391-2019-00011
• Device Sequence Number: 16729316
• Product Code: HRX
• UDI-Device Identifier: 10888277388550
• UDI-Public: 10888277388550
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/30/2019
• Device Catalogue Number: 72200728
• Device Lot Number: 399399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 05/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention