MAUDE Adverse Event Report: MEDLINE RENEWAL MEDLINE RENEWAL REPROCESSED DYONICS ARTHROSCOPIC SHAVER; ARTHROSCOPIC ACCESSORY

Model Number	72203013
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was not returned to medline renewal for evaluation, and no additional information was available at the time of the report and investigation.However, unused inventory of similar devices was returned to medline renewal as part of the complaint investigation.Review of the unused inventory confirmed the possibility of the reported device failure.Medline renewal performed a retrospective review of complaints and determined that this incident met the criteria for mdr reporting but was not filed within the required 30 day timeframe.Although no patient harm was reported, intervention may have been required to complete the procedure, therefore, medline renewal is retrospectively filing this medwatch report.(b)(4).
Event or Problem Description
It was reported that a reprocessed dyonics platinum arthroscopic shaver snapped apart in the knee during use.The report did not indicate that the device failure resulted in patient harm.

• Brand Name: MEDLINE RENEWAL REPROCESSED DYONICS ARTHROSCOPIC SHAVER
• Common Device Name: ARTHROSCOPIC ACCESSORY
• Manufacturer (Section D): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• MDR Report Key: 6088142
• Report Number: 3032391-2016-00016
• Device Sequence Number: 611953
• Product Code: HRX
• UDI-Device Identifier: 10888277354692
• UDI-Public: 10888277354692
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K012667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 72203013
• Device Catalogue Number: 72203013
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2016
• Initial Report FDA Received Date: 11/08/2016
• 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