MAUDE Adverse Event Report: MEDLINE RENEWAL DYONICS; FULL RADIUS BLADE (YELLOW) 4.5MM

Catalog Number	7205306RH
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during an unknown procedure, the reprocessed dyonics full radius blade (yellow) 4.5mm broke off in the patient.The device pieces were reportedly retrieved from the patient through an unknown method.Due to the reported incident and the required intervention to retrieve the broken device pieces from the patient, this medwatch is being filed.The sample is not available to be returned for evaluation.A review of the device history record was performed and this indicated that all processes were conducted as required at the time the lot was processed.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 during an unknown procedure, the reprocessed dyonics full radius blade broke off in the patient.

• Brand Name: DYONICS
• Common Device Name: FULL RADIUS BLADE (YELLOW) 4.5MM
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• MDR Report Key: 9273945
• Report Number: 3032391-2019-00026
• Device Sequence Number: 234594
• Product Code: HRX
• UDI-Device Identifier: 10888277374997
• UDI-Public: 10888277374997
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/04/2019

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 Catalogue Number: 7205306RH
• Device Lot Number: 387175
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 11/04/2019
• 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: Required Intervention