MAUDE Adverse Event Report: MEDLINE RENEWAL ARTHROSCOPIC SHAVERS; DYONICS RAZOR CUT BLADE (PINK) 4.5MM

Catalog Number	7205318RH
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a reprocessed dyonic razor cut blade had metal shavings which got to the patient during use for an unidentified procedure.Reportedly, the surgeon was not able to retrieve the metal shavings from the patient.There was no reported impact to the patient as result of the event.Another device was opened and the procedure continued without further incident.There was no report of an adverse patient consequence or need for medical intervention as a result of this event.Due to the reported incident and in an abundance of caution, medline renewal is filing this medwatch report.The sample was not returned for evaluation.A 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 a reprocessed dyonic razor cut blade had metal shavings which got to the patient during use for an unidentified procedure.

• Brand Name: ARTHROSCOPIC SHAVERS
• Common Device Name: DYONICS RAZOR CUT BLADE (PINK) 4.5MM
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• MDR Report Key: 7694862
• Report Number: 3032391-2018-00007
• Device Sequence Number: 13850304
• Product Code: HRX
• UDI-Device Identifier: 10888277375093
• UDI-Public: 10888277375093
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2018

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: 04/30/2021
• Device Catalogue Number: 7205318RH
• Device Lot Number: 385352
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 07/17/2018
• 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