MAUDE Adverse Event Report: MEDLINE RENEWAL DYONICS; ACROMIOBLASTER BURR (BRICK RED) 5.5MM

Catalog Number	7205669RH
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during a shoulder scope, the reprocessed dyonics acromioblaster burr was difficult to load into the hand piece.It was added that once the device was successfully loaded, it was difficult to remove.Per report, procedure time was extended for an extra 20 minutes to complete.The patient had to be administered additional anesthesia related to this procedure time extension.General anesthesia was used and there was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.Due to the reported event, this medwatch is being filed.A sample is not available to be returned for evaluation.A definitive root cause for the reported issue could not be determined at this time.The lot number for the reported device is unknown.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 acromioblaster burr was difficult to load into the hand piece.The procedure was extended for 20 minutes and patient required additional anesthesia.

• Brand Name: DYONICS
• Common Device Name: ACROMIOBLASTER BURR (BRICK RED) 5.5MM
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• MDR Report Key: 8818650
• Report Number: 3032391-2019-00018
• Device Sequence Number: 343346
• Product Code: HRX
• UDI-Device Identifier: 10888277375291
• UDI-Public: 10888277375291
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/23/2019

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: 7205669RH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 07/23/2019
• 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
• Patient Age: 31 YR