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

Model Number 375-544-000

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/21/2016

Event Type  malfunction  

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 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
• Type of Device: ARTHROSCOPE ACCESSORY
• Manufacturer (Section D): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• Manufacturer (Section G): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• Manufacturer Contact: brandi panteleon ; 2747 sw 6th st.; redmond, OR 97756 ; 5415164180
• MDR Report Key: 6071501
• MDR Text Key: 59017066
• Report Number: 3032391-2016-00038
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10888277379855
• UDI-Public: 10888277379855
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention