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

Catalog Number	7205306R
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 the reprocessed dyonics full radius blade (yellow) 4.5mm broke while in use.Per report, metal shavings were noticed in the surgical site and this 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 required medical intervention to retrieve the metal shavings from the surgical site, this medwatch is being filed.The device in question is not available to be returned for evaluation.The lot number associated with the device was not provided.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 reprocessed dyonics full radius blade broke while in use and metal shavings were noted in the surgical site.
Additional Manufacturer Narrative
Medline renewal received the device involved in this incident last 04/04/2019.The complaint of a broken reprocessed dyonics full radius blade was confirmed.Upon inspection of the received device, it was observed that the outer hub was cracked where the outer shaft connects to the hub base, causing the shaver to come apart.A potential root cause of this device failure is side force being applied to the shaver during use.A definitive root cause for this specific device failure could not be determined at this time.Review of the device history records was performed for lot number 385821 and this indicated that all processes were conducted as required at the time the lots were processed.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

• 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: 8429551
• Report Number: 3032391-2019-00002
• Device Sequence Number: 239269
• Product Code: HRX
• UDI-Device Identifier: 10888277374997
• UDI-Public: 10888277374997
• 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,Followup
• Report Date (Section B): 05/01/2019

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: 04/30/2021
• Device Catalogue Number: 7205306R
• Device Lot Number: 385821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 05/01/2019
• 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