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

Model Number	375-544-000
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We received a report indicating that the piece of a reprocessed arthroscopic shaver dislodged and fell into the patient during use.The physician was able to retrieve the broken piece during the procedure.Neither the device in question nor the lot number was returned to for evaluation, therefore we could not confirm if the device was reprocessed.Although multiple attempts to obtain information were made, due to the lack of information surrounding the incident, we do not have enough information to determine the failure mode or subsequent root cause of the failure.If more information is provided then this mdr will be updated.The user did not report patient harm or additional medical intervention required as a result of the incident.However in an abundance of caution, we are filing this medwatch report.Device not returned to manufacturer.
Event or Problem Description
We received a report indicating that a piece of a reprocessed arthroscopic shaver dislodged and fell into the patient during use.

• Brand Name: REPROCESSED ARTHROSCOPIC SHAVER
• Common Device Name: ARTHROSCOPIC ACCESSORY
• Manufacturer (Section D): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• MDR Report Key: 6301703
• Report Number: 3032391-2017-00002
• Device Sequence Number: 10913473
• Product Code: HRX
• UDI-Device Identifier: 10888277379855
• UDI-Public: 10888277379855
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 02/02/2017

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?: No
• Operator of Device: Physician
• Device Model Number: 375-544-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2017
• Initial Report FDA Received Date: 02/03/2017
• 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