MAUDE Adverse Event Report: MEDLINE RENEWAL MEDLINE RENEWAL REPROCESSED ARTHROSCOPIC SHAVER; ARTHROSCOPE 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)
Date of Event	09/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question (as well as the broken tip) was returned to medline renewal for evaluation.Upon receipt, medline renewal confirmed the device had been reprocessed.Our evaluation confirmed that the tip of the smaller, innermost shaft was missing and that the tip of the device was retrieved during the procedure.Our investigation also included a review of the device history record.We reconfirmed that all processes were conducted as required, and that the device met inspection and lubrication requirements prior to packaging and release.Unfortunately, the specific cause of the device failure is unknown at this time.Per the device instructions for use (ifu) if a rotating shaver or bur contacts another surgical instrument during activation, device integrity and effectiveness may be compromised.In the event that contact occurs, the user should inspect the tip before proceeding.Although the patient was not harmed, medical intervention was required to retrieve the device tip and obtain a new device, therefore medline renewal is filing this medwatch report in abundance of caution.
Event or Problem Description
Medline renewal received a report indicating that the tip of a reprocessed stryker formula aggressive plus cutter, model 375-544-000, broke off in the patient's shoulder during use.The report did not indicate that the device failure resulted in patient harm.Another device was readily available to complete the procedure; therefore no patient harm or additional medical intervention was reported as a result of the incident.

• Brand Name: MEDLINE RENEWAL REPROCESSED ARTHROSCOPIC SHAVER
• Common Device Name: ARTHROSCOPE ACCESSORY
• Manufacturer (Section D): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• MDR Report Key: 6071501
• Report Number: 3032391-2016-00038
• Device Sequence Number: 315980
• Product Code: HRX
• UDI-Device Identifier: 10888277379855
• UDI-Public: 10888277379855
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 11/01/2016

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: 01/30/2019
• Device Model Number: 375-544-000
• Device Lot Number: 280166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2016
• Initial Report FDA Received Date: 11/01/2016
• 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