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

Model Number	7205345
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to medline renewal for evaluation.We confirmed that the device was reprocessed and the reported issue was confirmed.Our investigation included both an inspection of the returned device, and a review of the device history record (dhr).We reconfirmed that all processes were conducted as required, and that the device met inspection and processing requirements prior to packaging and release.Unfortunately, the root cause of the device failure is unknown at this time.The tip was retrieved by the surgeon, however the procedure was delayed approximately 10 minutes in order to obtain another device.There was no additional medical intervention or adverse patient consequence related to the initial reported issue.However, due to the delay in the procedure, medline renewal is filing this medwatch report in an abundance of caution.
Event or Problem Description
The tip of a reprocessed dyonics incisor plus blade detached from the shaft and fell into the patient's shoulder during use.The tip was retrieved by the surgeon.

• Brand Name: REPROCESSED ARTHROSCOPIC SHAVER
• Common Device Name: ARTHROSCOPE ACCESSORY
• Manufacturer (Section D): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• MDR Report Key: 6140280
• Report Number: 3032391-2016-00043
• Device Sequence Number: 1248334
• Product Code: HRX
• UDI-Device Identifier: 10888277375215
• UDI-Public: 10888277375215
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K012667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/01/2016

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 Expiration Date: 11/30/2018
• Device Model Number: 7205345
• Device Lot Number: 270754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2016
• Initial Report FDA Received Date: 12/01/2016
• 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